Process Development Engineer
Title: Process Development Laboratory Engineer
Location: Foster City, CA
Duration: 18 months About the Role
Process Technologies & Development team is seeking a hands-on laboratory technician to support our new process development laboratory. This role executes studies, operates and maintains lab equipment, keeps accurate documentation, and drives continuous improvement of the lab. Work supports drug product process development, primary container and container closure evaluations, and product compatibility studies.
Key Responsibilities:
- Execute experiments per protocols and procedures, including sample preparation, testing, and data collection.
- Operate, maintain, and troubleshoot lab equipment (e.g., CCI/leak detection, headspace analysis, microscopy, filling, filtration, and mixing equipment).
- Support equipment installation, qualification, and routine calibration checks.
- Record data and results following good documentation practices (GDP), including notebooks, equipment logbooks, and study files.
- Support drafting and revision of SOPs, work instructions, and forms.
- Manage samples, consumables, and chemical inventory to keep the lab study-ready.
- Lead continuous improvement: 5S, lab organization, workflow improvements, templates, and checklists.
Minimum Qualifications:
- Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related field.
- 4+ years of hands-on laboratory experience (industry or academic).
- Strong attention to detail and documentation habits.
- Organized, reliable, and able to manage multiple tasks in a fast-paced setting.
Preferred Qualifications:
- Experience in pharmaceutical or biotech process development or drug product labs.
- Familiarity with CCI, extractables/leachables, or fill-finish operations.
- Experience with equipment qualification or new lab startup.
- Exposure to GDP or cGMP environments.