Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Project Engineer to join their project based in the San Francisco Bay Area on an initial 12-month contract.
Key Responsibilities
- Manage the procurement, installation, and integration of upstream (e.g., bioreactors, media prep) and downstream (e.g., filtration, chromatography, formulation) process equipment.
- Coordinate with design, construction, and commissioning teams to ensure equipment is installed and qualified per project specifications and timelines.
- Oversee vendor engagement, including technical reviews, FAT/SAT coordination, and delivery logistics.
- Support utility tie-ins, equipment start-up, and performance qualification (IQ/OQ/PQ) activities.
- Ensure compliance with GMP, safety, and engineering standards throughout the equipment lifecycle.
- Maintain and manage technical documentation, including datasheets, installation drawings, and turnover packages.
- Troubleshoot and resolve equipment-related issues in collaboration with cross-functional teams.
Required Experience & Skills
- sufficient years of experience in engineering roles focused on upstream and downstream equipment in pharmaceutical or biotech manufacturing.
- Strong understanding of bioprocessing systems, cleanroom environments, and GMP compliance.
- Experience with equipment installation, commissioning, and qualification.
- Familiarity with process utilities and facility integration.
- Excellent coordination, problem-solving, and communication skills.
- Bachelor's degree in Mechanical, Chemical, or Bioprocess Engineering (or related field).