- Novato, California, United States
- On-site
- Full-time · Mid
- $85K–$127K per year
- 2–5 years
Process Engineer responsible for developing PV protocols, coordinating execution of PV protocols, and supporting documentation and resolution of deviations in a GMP-regulated environment.
Compensation
National (US) Range $84,885—$127,144 USD
Responsibilities
- Meet with stakeholders and SMEs to gather input and develop PV protocols in preparation for and throughout Process Performance Qualification (PPQ)
- Coordinate execution of PV protocols, including sampling plans, testing, data tracking, and data collection
- Partner with internal functional groups (such as Manufacturing, Quality, Quality Control, and MSAT) and external CDMOs and contract laboratories to keep sampling, testing, and reporting on schedule
- Provide day-to-day oversight of vendor and CDMO PV activities, tracking milestones, deliverables, and open items and escalating risks to SMEs and project leadership
- Track and compile PV data, reviewing it for completeness and accuracy and flagging trends or unexpected results to SMEs
Requirements
- Bachelor’s degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field
- Nice to have: CDMO or vendor oversight
- Nice to have: Project management