Sr. Manufacturing Engineer; Pharma) San Clemente, CA

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 (M ) authoring and revisions
• Standard Operating Procedures (SOP) and Work Instructions (WI) authoring and revisions
• Support submission filings

• 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.

• 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
• Abilit…