Job Description

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).

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