Sr. Manufacturing Engineer (Pharma) San Clemente, CA

Glaukos Corporation•San Clemente, CA

8d•Onsite

About The Position

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.

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
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

Responsibilities

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.