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Principal Engineer (Validation)

Juncos, Puerto Rico
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 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.
 
Principal Engineer
DESCRIPTION 
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.

EDUCATION
  • Doctorate degree and 2 years of Engineering experience OR Master’s degree and 6 years of Engineering experience OR Bachelor’s degree in Engineering and 8 years of directly related experience.
RESPONSIBILITIES 
  • Introduces new or advanced technologies and/or concepts (equipment and process design).
  • Independently lead, plan and execute experiments, studies, or a series of experiments / studies to advance projects or technologies (equipment commissioning, equipment characterization, equipment qualification, equipment validation, process characterization, process validation).
  • Provides advanced data analysis and interpretation, assesses impact of the data on the project and implements recommendations.
  • Keeps current in field of scientific expertise and areas relevant to their function
    • Monitors field of expertise, including literature and technology development, and communicates relevant observations.
  • Initiates productive collaborations within and outside of the department or company
  • Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
  • Independently authors scientific reports, summary documents, and complex regulatory documents.
  • May author invention disclosure submissions and/or patents.
  • Leads role in department-wide support efforts such as safety, recruiting and committees.
  • Develops supervisory and mentoring skills.
  • Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.
  • Makes and communicates proactive decisions that contribute to the achievement of milestones.
  • Support non-standard operations including extended hours and/or weekends, as per business needs.
REQUIREMENTS/SKILLS
  • Educational background in Life Science and/or Engineering
  • Demonstrated leadership skills, initiative and self-motivation
  • Proficient in English and Spanish communication skills. Interacts effectively with variety of communication and working styles
  • Knowledge and/or experience of GMP regulations
  • Technical Writing
  • Demonstrated strong problem solving and conflict resolution.
  • Excellent time and project management skills to deliver projects on time and budget.
  • Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making.
  • Design, Commissioning, Characterization, Qualification & Validation (equipment or process) experience.

Ultimate Solutions Corp is an Equal Opportunity Employer
 

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