Blackfield Associates
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.
Bachelors degree in Mechanical, Chemical, or Bioprocess Engineering (or related field).