Job Description
The Senior Engineer I, Pharmaceutical , based in San Clemente, CA is responsible for development/pilot, clinical, and commercial manufacturing for pharmaceutical/combination products. The candidate supports the in-house manufacturing and contract manufacturing (CMOs) for development/pilot, clinical, and commercial campaigns. The candidate plays a key-role on the team including a hands-on role partnering with technicians to manufacture as needed. Additionally, the candidate will partner with R&D, CMC, QA, and Regulatory on the following:
- Development/study protocols, execution, and reports
- Execute equipment and facility qualification
- Technology transfer
- Device History Record (DHR) and Master Batch Record (MBR) authoring and revisions
- Standard Operating Procedures (SOP) and Work Instructions (WI) authoring and revisions
- Support submission filings
What will you do?
- Manufactures development, pilot, clinical, verification/validation, stability study campaigns, and commercial production whether internal or at CMO (hands-on as needed).
- Troubleshoots and performs investigations for process and equipment.
- Participate in development of completed per project plan with defined milestones, which are defined by the project engineer, but approved by the team and management.
- Organize internal and external activities and technicians to support manufacturing campaigns including all component and final product deliverables for accuracy and schedule.
- Ensures all pharma product development, manufacturing regulations, and quality requirements are met.
- Partners with Quality to ensure the Quality System (NCRs, deviations, CAPA, supplier notification (SCAR), ECOs, change controls, etc) documents appropriately comply with pharma product regulations.
- Responsible for equipment, process, and product verifications and validations (IQ, OQ, PQ, pFMEA, MVP, and PV).
- Supports the stability studies for the pharma projects.
- Responsible for applying fundamental and advanced (depending on level) engineering principles, concepts, theories and techniques to solve complex problems related to product development / design and manufacturing while following company standard practices and procedures, and related specification.
- Develops robust manufacturing processes that meet Corporate/Operations objectives for cost, quality, manufacturability, vendor quality, capacity, robustness, simplicity, validation, through put, etc., while meeting all regulatory, quality, and commercial requirements.
How will you get here?
- Bachelor’s degree in Engineering or Science with 5-8 years direct clinical and/or commercial GMP experience within a pharmaceutical or biotechnology environment
- Experience in clean room GMP/GLP environments (ISO 5-ISO 8)
- Strong combination of technical, business, and project management skills
- Developing processes, equipment, specifications, procedures, training, etc. at pilot/ clinical/commercial scale(s)
- Working with Purchasing/Supply Chain/Materials Management groups and component/API/excipient/raw material vendors to manage pharmaceutical component purchasing, inventory, and manufacturing supply
- With limited direction from department director or Vice President including limited or no guidance on task development. Work may be reviewed for accuracy and overall content upon completion.
- Lead projects and investigations with limited guidance.
- Organization and authoring of documentation (development, manufacturing, validations, studies, builds, components, etc.) that meets pharma and medical device GMP requirements in preparation for submission filings
- Success in developing scaled up process/equipment and transfer from Pilot to Clinical/Commercial Production.
- Providing cGMP and GDP manufacturing documentation and hands-on training for operations
- Ability to author V&V and some DHF deliverables with guidance
- SolidWorks or Visio (drawings, flowcharts) experience
- Minitab or JMP (statistical analysis) experience
- Design of Experiments (DOE) experience
