Process Development Laboratory Engineer

Pay Rate Range: $80.00 - $86.33/hr on W2 Position Summary Seeking a highly motivated Process Development Laboratory Engineer for an 18-month contingent contract role at our Foster City headquarters. This position sits within the Process Technologies & Development (PT&D) organization. This position is responsible for executing laboratory-scale process development, managing design transfers, and supporting equipment and process validation lifecycle activities. The successful candidate will bridge the gap between bench-scale experimental engineering and scaled commercial drug-device combination product manufacturing. Core Responsibilities Process Development & Technology Transfer: Set up, operate, and maintain laboratory-scale process equipment and assembly systems. Support design transfer activities to translate design inputs into scaled commercial manufacturing specifications. Coordinate technology transfer packages and process maps for internal facilities and external CDMO networks. Validation & Equipment Qualification: Author, execute, and review lifecycle validation protocols, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ). Utilize paperless validation and lifecycle management software to manage templates and ensure traceability. Maintain GMP right-to-operate status through standard equipment requalification and periodic system reviews. Process Monitoring & Quality Support: Implement and support Process Analytical Technology (PAT) systems for real-time process monitoring and control. Investigate deviations, conduct technical root cause analyses, and author change controls. Apply Failure Mode and Effects Analysis (FMEA) to identify and mitigate process risks. Data Analysis & Modeling: Design and execute statistical Design of Experiments (DoE) to establish robust process boundaries. Utilize statistical software to perform process capability, ANOVA, and Statistical Process Control (SPC) analyses.