Job Openings | Ultimate Solutions

Engineer-Maintenace - Puerto Rico, PR

Thu, 09 Apr 2026 09:39:23 GMT

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.

• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.

• Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization

• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.

• Lead the implementation of equipment improvements projects

• SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.

• Support equipment troubleshooting within the functional area or in the scope of technical expertise.

• Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization

Education/Experience:
Master’s degree or bachelor’s degree in Engineering & 2 years of engineering experience.

Requirements/Skills:

Experience in data analysis.
Optional knowledge of aseptic operation (filling and support).
Recommended experience in engineering reliability elements and process excellence.
Recommended experience in maintenance systems and asset management.
Knowledge of pharmaceutical/biotech processes.
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Demonstrated skills in problem solving and applied engineering.
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
- Problem solving and applied engineering.
- Basic technical report writing
Verbal Communication
Comprehensive understanding of validation protocol execution requirements
Demonstrated skills in the following areas:
- Basic technical presentations, personal organization
- Validation Protocol Writing
- Dealing with and managing change
- Technical (Equipment Specific).
- Analytical Problem Solving
- Computer Literacy

Ultimate Solutions Corp is an Equal Opportunity Employer.

EHS Specialist - AutoPak, Caguas, PR

Fri, 27 Mar 2026 15:08:15 GMT

AutoPak Engineering by Ultimate Solutions Corp es un líder en la manufactura de equipos de empaque y automatización, y actualmente busca un Especialista de Salud y Seguridad Ocupacional (EHS). La persona será responsable de desarrollar, implementar y mantener los programas de salud, seguridad y ambiente en la planta de manufactura, garantizando el cumplimiento con las leyes y regulaciones aplicables de Puerto Rico (PR OSHA, Junta de Calidad Ambiental, Departamento del Trabajo) y las políticas corporativas. Su objetivo principal es prevenir accidentes, promover prácticas seguras de trabajo y asegurar un ambiente laboral saludable y sostenible.

Responsabilidades:

Asegurar el cumplimiento con las regulaciones de PR OSHA, EPA, Junta de Calidad Ambiental, y demás agencias locales y federales aplicables.
Monitorear cambios en leyes y regulaciones aplicables en materia de seguridad y ambiente (OSHA PR, EPA, DTOP, JCA, etc.).
Mantener actualizados los permisos ambientales y de manejo de desperdicios peligrosos (si aplica).
Preparar y presentar reportes regulatorios requeridos por las agencias pertinentes.
Revisa e interpreta las políticas internas, leyes y normativas vigentes relacionadas con EHS, para garantizar que los procedimientos y prácticas en planta estén alineados con los requisitos legales y corporativos.
Actuar como enlace con agencias regulatorias durante visitas o inspecciones oficiales.
Desarrollar, revisar y actualizar programas de seguridad como: Control de Energía (LOTO), Trabajo Caliente, Protección Respiratoria, Ergonomía y Manejo de Materiales.
Realizar las inspecciones rutinarias de planta, talleres, y áreas de trabajo (soldadura, doblado, CNC, corte plasma, ensamblaje, pintura, etc.).
Realizar la investigación de accidentes, incidentes y cuasi-accidentes, documentar hallazgos y dar seguimiento a las acciones correctivas.
Asegurar que todos los equipos cuenten con protecciones, etiquetas y guardas de seguridad según las normas aplicables.
Coordinar, aprobar y supervisar el uso adecuado del equipo de protección personal (EPP) por parte del personal.
Actualizar y comunicar los procedimientos de trabajo seguro (PTS) conforme a la operación y normativas aplicables.
Desarrollar evaluaciones de riesgos por puesto y proceso, en colaboración con supervisores y líderes de equipo.
Llevar control de estadísticas de accidentes e incidentes, analizando tendencias y estableciendo medidas de control.
Desarrollar y ofrecer adiestramientos a empleados y contratistas en temas de seguridad, salud ocupacional y ambiente.
Mantener los registros de adiestramientos y certificaciones actualizados.
Capacitar al personal nuevo en las políticas y prácticas de EHS durante su capacitación inicial.
Desarrollar campañas de concientización en temas clave de EHS mediante carteles, boletines, charlas y otras herramientas visuales.
Coordinar exámenes médicos ocupacionales según las tareas (soldadores, operadores CNC, manejo de químicos, etc.).
Colaborar con Recursos Humanos en el manejo de casos de accidentes laborales y el proceso de compensación al trabajador (CFSE).
Asegurar que el empleado obtenga la atención de primeros auxilios en caso de emergencias menores y coordinar el traslado en situaciones médicas más complejas.
Realizar auditorías internas ambientales y apoyar en auditorías externas o gubernamentales.
Implementar o mantener programas de reciclaje, manejo de desperdicios sólidos y peligrosos.
Controlar el uso y disposición adecuada de aceites, solventes, pinturas y gases industriales.
Monitorear emisiones, vertidos y consumo energético, promoviendo prácticas sostenibles.
Preparar informes ambientales periódicos requeridos por las agencias locales y corporativas.
Fomentar una cultura de seguridad a través de comunicación efectiva, campañas y actividades de reconocimiento.
Servir como enlace principal entre la empresa, agencias reguladoras y aseguradoras en temas de EHS.
Promover programas de bienestar y ergonomía en el trabajo.
Participar activamente en proyectos Kaizen o iniciativas de Lean Manufacturing relacionados con seguridad o sostenibilidad.
Identificar oportunidades de mejora continua en procesos de EHS y liderar su implementación.
Mantener actualizados los registros de inspecciones, capacitaciones, auditorías, permisos, residuos y eventos relacionados con EHS.
Gestionar la base de datos de hojas de seguridad (SDS/MSDS) y garantizar su disponibilidad en todas las áreas necesarias.
Utilizar herramientas digitales y plataformas corporativas para documentar y reportar métricas e indicadores clave de EHS.
Apoyar la implementación y mantenimiento de sistemas de gestión como ISO 14001 (gestión ambiental) e ISO 45001 (seguridad y salud ocupacional).
Elaborar informes mensuales de desempeño de EHS para la gerencia.
Cualquier otra tarea asignada por su supervisor o la gerencia de AutoPak por necesidad operacional.

Requisitos Físicos y Mentales:

Debe contar con los requisitos físicos necesarios para realizar las funciones esenciales del puesto.
Capaz de trabajar de manera segura y seguir todas las políticas y procedimientos de seguridad de la empresa.
Capaz de levantar de 2 a 50 libras regularmente, subir escalones y escaleras, y estar de pie o caminar durante 2 a 3 horas.
Debe poseer la capacidad de realizar múltiples tareas.
Debe poseer la capacidad de trabajar bajo presión.
Debe tener la capacidad de realizar múltiples tareas a la vez.
Debe tener la capacidad de trabajar bajo presión.
Habilidad para entender problemas complejos y colaborar para explorar soluciones alternativas.
Habilidad para comprender puntos de vista opuestos sobre temas altamente complejos y negociar e integrar diferentes perspectivas.
Habilidad para redactar cartas, esquemas e informes básicos, o para comunicar oralmente información técnica.

Experiencia Requerida:

Mínimo 3 a 5 años de experiencia en funciones de EHS en entornos industriales o de manufactura metálica.
Experiencia demostrable en auditorías, investigación de accidentes y desarrollo de programas de seguridad.

Educación y Adiestramientos Requeridos::

Bachillerato en Ciencias Ambientales, Ingeniería Industrial, Seguridad Ocupacional o campo relacionado.
Certificaciones: OSHA 30 Horas (General Industry), CPR/First Aid, ISO 45001, o equivalentes.

AutoPak Engineering Corp se compromete a ofrecer igualdad de oportunidades de empleo a todos los empleados y solicitantes, independientemente de su raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, información genética, estado civil o condición de veterano.

Project Manager - Juncos, PR

Thu, 26 Mar 2026 08:30:38 GMT

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

Description:
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

Duties/Responsibilities:
-Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
-Manage competing timelines and prioritize critical tasks.
-Establish and achieves project standards for work quality and quantity.
-Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
-Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
-Maintain and track project budget(s).
-Reconcile the use of resources for the projects.
-Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
-Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
-Actively participate in directing the evolution and defining the role of the project.
-Ensure the project goals and objects are well understood by the various functional areas.
-Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
-Maintain the master project plan and schedule for assigned projects.
-Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
-Provide department management with project management support on an as needed basis as well as for special projects.
-May manage and direct the activities of project support staff.
-Conduct annual performance reviews, and provides career counseling and general guidance.
-Identify or lead focus area projects within the overall function of project management or related projects.
-Generate periodic updates and prepare formal presentations for required forums.
-Generate individual and more complex reports utilizing various resources.
-Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
-Ensure project work complies with practices, policies and standard operating procedures.
-Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
-Anticipate resource needs and communicate to management sponsors.

Education/Experience:
Doctorate degree or Master’s degree and 2 years of Project Management experience or Bachelor’s degree and 4 years of Project Management experience.

Competencies/Skills:

-PM experience
-Knowledge in Scum/Agile Framework/Agile Framework
-Use of Smartsheet/Use of Power BI
-Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
-Skills in working under time pressure, and effectively in a team matrix environment.
-Practical project management software and spreadsheet skills, proficient computer operation skills.
-Good organizational skills, detail-oriented & accurate, analytical skills.
-Must be a team player, self-starter, persistent, tactful, and persuasive.
-Fully Bilingual (Spanish/English).

Specialist Quality Control - Puerto Rico, PR

Wed, 25 Mar 2026 16:02:05 GMT

Responsible for providing technical guidance,
Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
Resolve technical issues and troubleshoot for assays as necessary
Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
Manage existing and/or develop and implement new programs, processes and methodologies.
Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
Approve lab investigations, Lead audit teams
May serve as subject matter expert to develop technical training.
May perform routine work in a specific area of responsibility as necessary.
Represents the department/organization on various teams,
Independently responsible for following through on multi-site action items.
May interact with regulatory agencies regarding area(s) of responsibility including written responses.
May resolve issues with outside resources.
Performs special projects as requested by supervisor,
May supervise employees as necessary to meet technical requirements.

SKILLS

Excellent communication skills, facilitation and presentation skills.
Excellent technical writing skills.
Scientific Data Analysis
Strong Technical Writing (English and Spanish) mainly focuses
Strong knowledge in Microsoft Excel as a Tool for Data Analysis
Good Communication skills
Project Management
Knowledge in Computer System and Method Validation (Experience preferable)
Strong knowledge and experience with quality process management
Knowledge on equipment validation and troubleshooting (Experience preferable)
Agile on prioritization of critical tasks
Ability to develop inspection or qualification protocols in a short timeframe period.
Strong negotiation skills
Usage of KNEAT platform and Kaye validator (Experience Preferred)

Ultimate Solutions Corp is an Equal Opportunity Employer.

Sr Engineer - Juncos, PR

Wed, 25 Mar 2026 15:55:24 GMT

Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering knowledge in planning and conducting projects.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

REQUIREMENTS/SKILLS
• Engineer with experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
•Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope
• Demonstrated skills in the following areas:
o Problem solving and applied engineering.
o Basic technical report writing
o Verbal communication
• Comprehensive understanding of validation protocol execution requirements.
• Demonstrated Skills in the following areas:
o Basic technical presentations
o Personal Organization
o Validation Protocol Writing
o Dealing with and managing change
o Technical (Equipment Specific)
o Analytical Problem Solving
o Computer Literacy
• Specialized equipment/process expertise
• In-depth knowledge of validation processes and requirements as applied to new equipment installations
• Interacts effectively with variety of communication and working styles
• Ability to independently determine when additional internal resources are required to solve problems
• Ability to handle multiple projects at one time
• Demonstrated Skills in the following areas:
o Schedule development
o Facilitation
o Collaboration
o Basic project management
o Completion and follow-up
• Established expertise in at least 3 separate areas of engineering technology.
• Ability to independently determine when additional external resources are required to solve problems
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Working knowledge of financial analysis tools
• Ability to delegate and manage the project work of others
• Demonstrated Skills in the following areas:
o Negotiation, persuasion and facilitation
o Collaboration
o Project cost development
o Conflict Resolution
o Leadership and teambuilding
• Management of contractors and vendors

Ultimate Solutions Corp is an Equal Opportunity Employer

Principal Engineer - Juncos, PR

Mon, 16 Mar 2026 17:02:14 GMT

Description:
The Principal Engineer manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes. Employs an extensive technical knowledge of more than one area of engineering (process, unit operations, and equipment project) in complex process characterization, optimization, scale-up, or manufacturing support projects.

Responsiblities:
1. Establish engineering policies for a major segment of the company.
2. Interpret, execute, and recommend modifications to company-wide policies.
3. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.
4. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
5. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
6. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
7. Plan, organize and coordinate work of a staff of engineers and/or technicians.
8. Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications.
9. Established a corporate Engineering resource, specializing in more than one area of engineering.
10. Designs, executes, implements and directs engineering or process projects which significantly contribute to attaining high priority goals.

Education:
Doctorate degree and 2 years of Engineering experience OR Master’s degree and 4 years of Engineering experience OR Bachelor’s degree in Engineering and 6 years of directly related experience.
Mechanical or Chemical Engineer, preferred.

Preferred Qualifications:

Experience Working with Clean Utilities Systems such as Distilled Water, Purified Water, RO System.
Experience working on Clean Gases [Process Air, GMP gases supply like Oxygen, Nitrogen]
Experience documenting and managing Deviation [non-conformance]
Proficient in GMP documentation and the process improvement of SOP documents.
Ability to work on Critical Operation and Capital project environment.
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
- Problem solving and applied engineering.
- Basic technical report writingo Verbal communication
Comprehensive understanding of validation protocol execution requirements.

⚠️ Employment visa sponsorship is not available.
⚠️ Not open for Corp-to-Corp arrangements.

Ultimate Solutions Corp is an Equal Opportunity Employer.

Sr Automation Engineer - Carolina, PR

Mon, 16 Mar 2026 16:07:28 GMT

Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For over 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical, biotechnology, medical device, and logistics sectors.

Description
The Senior Automation Engineer will support site automation control systems and manufacturing and utilities automation operations under an 8 hours per day, 7 days per week (8/7) support model. This service is intended to ensure continuous, reliable automation coverage aligned with manufacturing operations at the site.

Responsibilities:

Troubleshoot, diagnose, and resolve incidents related to PLCs, SCADA, DCS, OSI PI, communication interfaces, control system instrumentation, and networked automation manufacturing equipment.
Provide onsite coverage during overnight operations, ensuring rapid response to alarms, system faults, and equipment failures.
Perform root cause analysis for automation incidents and support corrective and preventive actions (CAPA) as required. Coordinate and /or perform replacement of parts as needed.
Execute and maintain the automation preventive maintenance (PM) agenda, ensuring scheduled tasks are completed accurately and on time.
Actively support automation project tasks, system upgrades, and improvements under the supervision of the Lilly Automation Engineer Representative and in alignment with site Quality Practices and Engineering standards.
Provide support for validation activities, including execution of protocols, testing, protocols and CSV documentation authoring, and resolution of findings related to automation systems.
Provide shift turnover communication and documentation including system status, incidents, corrective actions, preventive maintenance execution, and pending follow up items.
Ensure compliance with all cGMP, safety, cybersecurity, training plan, data integrity, and site Quality Practices requirements.
Occasional support during startup, shutdown, or special events may be requested with prior notice.

Education:

BS in Engineering (Computer, Electrical, or Mechanical) or a combination of equivalent education and experience.

Requiremens/Sills:

Minimum 5 years of experience in Industrial Automation support in GMP environments
Demonstrated experience with Rockwell, Siemens, PI systems, and Kepware.
Kneat experience required.
References for at least three similar projects completed in the last 36 months
Certifications: ISA 95, ISA 88, and GAMP 5 preferred

⚠️ Employment visa sponsorship is not available.
⚠️ Not open for Corp-to-Corp arrangements.

Ultimate Solutions Corp is an Equal Opportunity Employer.

Sr Associate Tech Engineering - East, PR

Tue, 03 Mar 2026 14:00:02 GMT

Description
The Sr. Associate Technical Engineering will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.

Responsibilities
1. Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
2. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
3. Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
4. Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
5. Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
6. Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
7. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
8. Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.

Education
Master’s degree or Bachelor’s degree and 2 years of Engineering experience O or
Associate degree and 6 years of directly related experience

Requirements

Available to work 12 hours shifts AM or PM
Knowledge on Mechanical Equipment Adjustment/Troubleshooting
Knowledge on PLC Systems Troubleshooting– Rockwell
Knowledge on Vision Systems Troubleshooting/Adjustment– Cognex
Knowledge on cGMP’s
Knowledge on Systech Vision System Troubleshooting\Adjustments.
Nice to have - Work experience on FDA regulated industries.
Knowledge on basic control systems hardware.
Preferred skills in the following areas:
Leadership and teambuilding
Verbal communication
Written Communication/Technical Writing
Organization
Facilitation
Dealing with and managing change
Comprehensive understanding of validation protocol requirements
Technical (Equipment Specific)
Analytical Problem Solving
Project Management & Planning
Scheduling
Computer Literacy

Ultimate Solutions Corp is an equal opportunity employer.

Sr Associate Manufacturing Engineer (Automation) - East, Puerto Rico

Tue, 03 Mar 2026 13:52:14 GMT

DESCRIPTION
The Sr. Associate Manufacturing Engineering will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.

EDUCATION

Master or
Bachelor's Degree in Engineering and two (2) years of Engineering Experience.

PREFERRED QUALIFICATIONS

Knowledge on PLC Systems Trobleshooting– Rockwell
Knowledge on Vision Systems Trobleshooting/Adjustment– Cognex
Knowledge on cGMP’s
Knowledge on Systech Vision System Trobleshooting\Adjustments.
Nice to have - Work experience on FDA regulated industries.
Knowledge on basic control systems hardware.
Available to work 12 hours shifts AM or PM

RESPONSIBILITIES
1. Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
2. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
3. Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
4. Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
5. Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
6. Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
7. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
8. Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.

REQUIREMENTS/SKILLS
• Leadership and teambuilding
• Verbal communication
• Written Communication/Technical Writing
• Organization
• Facilitation
• Dealing with and managing change
• Comprehensive understanding of validation protocol requirements.
• Technical (Equipment Specific)
• Analytical Problem Solving
• Project Management & Planning
• Scheduling
• Computer Literacy

Applicants must be currently authorized to work for any employer in the United States on a full-time unrestricted basis. Employment visa sponsorship is not available.
Not open for Corp-to-Corp arrangements

Ultimate Solutions Corp is an Equal Opportunity Employer.

C&Q Engineer, Sr. - Columbus, OH

Mon, 16 Feb 2026 07:18:29 GMT

About Ultimate Solutions Corp.

Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For over 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical, biotechnology, medical device, and logistics sectors.

Key Responsibilities

Plan, coordinate, and execute commissioning and qualification (C&Q) activities for Packaging Equipment.
Develop and review C&Q documentation, including protocols, test scripts, reports, and traceability matrices.
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
Ensure equipment and systems meet design specifications, user requirements, and applicable regulatory standards.
Collaborate with project managers, engineering, validation, automation, quality, and manufacturing teams to align on project timelines and deliverables.
Troubleshoot and resolve issues identified during C&Q execution.
Support change control, deviation investigations, and CAPA activities.
Maintain compliance with GMP, safety, and environmental requirements throughout project execution.
Ensure all C&Q documentation is complete, accurate, and audit-ready.

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, or related field.
6+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
Strong and proven knowledge of the complete equipment validation life cycle, including URS, FAT/SAT, IQ, OQ, and PQ documentation and execution.
Experience with Packaging Equipment is strictly required – particularly Dividella Cartoner and ATS Assembly Systems.
Deep understanding of GMP regulations, ISPE Baseline Guides, and ASTM E2500 principles.
Ability to read and interpret P&IDs, electrical schematics, and system design documents.
Experience with automation systems, process equipment, and utilities in pharmaceutical or biotechnology manufacturing.
Excellent technical writing, analytical, and organizational skills.
Strong communication and teamwork abilities.

Additional Requirements

Ability to multi-task and work under pressure.
Capable of understanding complex problems, collaborating across disciplines, and developing effective solutions.
Ability to negotiate and integrate different viewpoints in highly complex situations.
Proficiency in composing technical documents, outlines, and concise reports, as well as communicating technical information effectively.

⚠️ Not open for Corp-to-Corp arrangements

Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Process Engineer - Puerto Rico, PR

Fri, 30 Jan 2026 08:57:01 GMT

Lead/support projects or initiatives, including but not limited to: new products, process and technology introductions.
Participates in projects involving other departments and activities.
Coordinates communications and interact within end users and machine manufacturers or suppliers.
Evaluates process trends (Ex. Yield, OEE) to drive improvements of business results.
Responsible for problem identification, root cause analysis, project management, financial analysis, efficiency or productivity improvement, and problem resolution.
Support process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes.
Evaluate data generated through studies using statistical analytical methods.
Responsible for the development and/or revision of production standards and Manufacturing/Packaging process to assure utilization of best process.
At higher levels, may lead and direct the work of others.
Build and execute validation strategies.
Must possess a solid understanding of FDA Validation guidelines.
Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Prepares and coordinate qualification activities.
Communicate with the staff and management on ways of implementing plans and recommendations.
Responsible for designing, document and implementing manufacturing and/or packaging processes & equipment.
Familiar with a variety of field concepts, practices, and procedures.

EDUCATION
Bachelor’s degree in Engineering (3 -5 years of experience)

REQUIREMENTS/SKILLS

Experience in Medical Device or Pharmaceutical industry is required
Project Management experience managing multi-sites project is a plus
GMP & ISO knowledge, understanding and experience
Computer skills and use of software application(s). Strong computer background (MS Office, MS Project Management, Word, Excel, Outlook, etc.)
Strong knowledge on statistics, problem solving and lean tools.
Effective interactions in a team environment
Team player, self-starter, persistent, tactful, and persuasive
Good organizational skills, detail-oriented & accurate, analytical skills
Effective verbal and written communication skills (writing and presentations)
Able to work with minimum or no supervision
Fully Bilingual (English and Spanish)

ADDITIONAL REQUIREMENTS

Must have knowledge in: Process Validations, Equipment Validations, Equipment Qualifications, Test Method Validations. Manufacturing Procedures generation, Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ.
Technical Writing Skills

Ultimate Solutions Corp is an equal opportunity employer.

Automation Systems Integrator - Puerto Rico, PR

Tue, 27 Jan 2026 10:35:12 GMT

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries globally. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

Description
The Automation Systems Integrator is primarily responsible for the design, implementation, validation, and for sustaining integrations between the Manufacturing Execution System (MES) and shop-floor Automation (PLC/DCS/SCADA) Industrial Systems, data historians, and plant IT/OT services. Will ensure compliant, reliable data flows for EBR, and interfaces for new or existing industrial automation system across regulated manufacturing operations.

Education

BS in Engineering (Computer, Electrical, or Mechanical) or a combination of equivalent education and experience.

Responsibilities

Develop integration design strategy including the communication with manufacturer and stakeholders.
Generate Interface Design Specification Documents and/or ISA 95 Architecture Document.
Configure MES and Automation communication protocol interfaces for EBR, OEE process monitoring, historian and other data analytics solutions.
Develop validation package (URS, TMX, DSP, IQ/OQ/PQ)
Prepare SOPs and training materials when applicable

Requirements

•Minimum 5 years of experience in MES–automation integration projects in GMP environments

• Demonstrated experience with Rockwell, Siemens, PI systems, and Kepware.

• Certifications: ISA-95, ISA-88, and GAMP 5 preferred

Not open to Corp-to-Corp arrangements.

Ultimate Solutions Corp is an equal opportunity employer.

Quality Engineer - Puerto Rico, PR

Mon, 12 Jan 2026 15:00:09 GMT

About Ultimate Solutions Corp.

Ultimate Solutions Corp. is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide.

Position Summary

The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test method validations, documentation review and approval, and support of quality investigations and CAPAs. The candidate will apply Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications.

Responsibilities

Execute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports.
Perform and support test method validations to ensure compliance with intended use and regulatory requirements.
Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation.
Support the development, execution, and effectiveness verification of CAPAs.
Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures.
Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements.
Develop, implement, and maintain Sampling Plans based on risk and statistical rationale.
Support and execute Change Control activities, including impact assessments and cross-functional coordination.
Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks.
Ensure compliance with GMP, ISO, and applicable regulatory requirements.

Education

Bachelor’s degree in Engineering or Sciences.
3–5 years of relevant experience in a regulated industry.

Requirements / Skills

Required experience in the Medical Device or Pharmaceutical industry.
Strong knowledge and practical experience with GMP and ISO standards.
Strong computer skills, including proficiency with MS Office applications (Word, Excel, Outlook) and MS Project Management tools.
Solid knowledge of statistics, problem-solving methodologies, and Lean tools.
Ability to work effectively in a team-based environment.
Demonstrated ability to be a team player, self-starter, persistent, tactful, and persuasive.
Strong organizational skills, attention to detail, analytical thinking, and accuracy.
Effective verbal and written communication skills, including technical writing and presentations.
Ability to work with minimal or no supervision.
Fully bilingual in English and Spanish.

Ultimate Solutions Corp. is an Equal Opportunity Employer.

C&Q Engineer, Jr. - Columbus, OH

Wed, 27 Aug 2025 10:24:09 GMT

Plan, coordinate, and execute commissioning and qualification activities for equipment, utilities, automation systems, and facilities.
Develop and review C&Q documentation including protocols, test scripts, reports, and traceability matrices.
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
Ensure equipment and systems meet design specifications, user requirements, and applicable regulatory standards.
Work closely with project managers, engineering, validation, automation, quality, and manufacturing teams to align on project timelines and deliverables.
Troubleshoot and resolve issues identified during C&Q execution.
Support change control, deviation investigations, and corrective/preventive action (CAPA) activities.
Maintain compliance with GMP, safety, and environmental requirements throughout project execution.
Ensure C&Q documentation is complete, accurate, and audit-ready.

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, or related field.
3+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
Strong understanding of IQ/OQ/PQ processes, GMP regulations, and industry standards (ISPE Baseline Guides, ASTM E2500).
Ability to read and interpret P&IDs, electrical schematics, and system design documents.
Experience with automation systems, process equipment, and utilities in pharmaceutical or biotechnology manufacturing.
Strong attention to detail and technical writing skills.
Effective communication and teamwork skills.

Preferred Experience

Experience with risk-based C&Q approaches.
Familiarity with validation software tools for protocol development and execution.
Project management experience in a schedule-driven environment.
Knowledge of cleaning, process, and computer systems validation principles.

C&Q Engineer, Lead - Columbus, OH

Wed, 13 Aug 2025 10:21:01 GMT

Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.

Description:
The Commissioning and Qualification (C&Q) Lead will join a highly technical team for a start-up manufacturing site. They are responsible for overseeing and executing C&Q activities for facilities, utilities, systems, and equipment to ensure compliance with regulatory requirements and company standards. This role involves planning, coordinating, and managing C&Q efforts across capital projects or ongoing operational improvements.The Ultimate Team is in charge of the commissioning and qualification of several fully automated packaging lines for biotech drug product.

Education:

BS in Science or Engineering
Minimum 10 years of related experience

Responsibilities:

Manage the technical aspect of each line, provide support to the packaging engineering team and be responsible for packaging equipment validations.
Manage the rest of the team working in the line, leading the team to the successful execution of validation activities.
Communicate with the PM to maintain the entire project metrics.
Must possess a solid understanding of FDA validation guidelines and industry best practices for this field and be able to implement packaging validation standards on a daily basis.
Assure that policies and procedures are implemented to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Review, complete, and approve regulatory documentation.
Communicate with the staff and management on ways of implementing plans and recommendations.
Assure project deliverables are done in a timely manner.

Requirements/Skills:

Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device) of different vendors and preferably will have experience working in any of the client’s sites worldwide.
Strong leadership and people management skills.
Availability to work in different shifts, extended shifts and weekends as required.
Able to work with minimum or no supervision.
Strong verbal & written communication skills in English.
Not open for Corp-to-Corp arrangement.

Addtional Requirements:

Must possess the ability to multi-task
Must possess the ability to work under pressure.
Ability to understand complex problems and to collaborate and explore alternative solutions.
Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
Ability to compose letters, outlines, and basic reports and/or to orally communicate technical information.