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.
Description The Manufacturing/Packaging Sr Scientist will, independently lead the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Serve as the primary production process owner for critical process systems or an operational area. May supervise Manufacturing
Doctorate degree and 2 years of directly related experience OR
Master’s degree and 6 years of directly related experience OR
Bachelor’s degree and 8 years of directly related experience.
Educational background in Life Science, Chemistry, Biochemistry, Industrial Biotechnology, Bioengineering, Chemical/Biochemical Engineering and/or Mechanical Engineering
Responsibilities Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Lead trouble shooting of production process equipment. Generate training materials and provide training on scientific or technical aspects of the process. Participate in the design of critical processes and/or facilities.
Considered to be the subject matter expert in an operational area.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. In conjunction with PD own process-monitoring parameters and control limits. Review process-monitoring data and assess deviations. Approve routine reports. Initiate corrective actions due to process-monitoring deviations
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Responsible to lead more complex investigations. Lead NC/CAPA trend evaluation. May be responsible for all management level NCs and associated CAs for a functional area.
Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May generate and approve process validation protocols and reports. Lead execution of process validation. Lead major process validation projects.
May participate in regulatory inspections. Review and provide input to regulatory submissions applicable to area of responsibility. Support gathering of data and formulation of responses during and after regulatory inspections. Respond to inspector questions as necessary. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc
May present process overviews to inspectors and accompany inspectors on tours of process areas.
Participate in the (New Product Introduction) NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Develop NPI timelines including milestones and deliverables. Communicate with NPI stakeholders on timelines progress. Serve as NPI core team leader. Able to lead multi-departmental teams and facilitate decision-making. Ensure appropriate resources are in place to perform NPI activities. Write NPI campaign summaries.
Represent manufacturing on the Global Operational Teams (GOTs).
Assist manufacturing change owner on Change Control (CCRB) packages impacting the process. Serve as the manufacturing change owner on CCRB packages impacting the process.
Participate on the assessment or implementation of special projects or initiatives. Assist area manager in prioritization of projects. Serve as production project manager in manufacturing projects and cross functional projects.
Requirements & Skills
Advanced organizational, technical writing and presentation skills.
Excellent project management skills.
Able to lead major/trend deviation investigations throughout the whole lifecycle, including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring investigation reports, managing trackwise record, presenting at regulatory inspections
Strong Technical Writing Skills and excellent written and verbal communication skills in English and Spanish.
In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe).
Detailed technical understanding of bio-processing unit operations
Compliance/Regulatory knowledge and audit interaction experience
Experience leading cross-functional teams for Root Cause Analysis and problem solving.
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Strong presentation and project management skills
Ultimate Solutions Corp is an equal opportunity employer.