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.