Blackfield Associates
Project Engineer - Pharmaceutical Manufacturing
Blackfield Associates, San Mateo, California, United States, 94409
Blackfield Associates is excited to partner with a leading global pharmaceutical manufacturer in search of a skilled Project Engineer to contribute to innovative projects on an initial 12-month contract.
Key Responsibilities
Oversee the procurement, installation, and integration of advanced upstream (e.g., bioreactors, media preparation) and downstream (e.g., filtration, chromatography, formulation) process equipment.
Collaborate effectively with design, construction, and commissioning teams to ensure timely and compliant equipment installation and qualification.
Engage with vendors through technical reviews, manage FAT/SAT coordination, and streamline delivery logistics.
Facilitate utility tie-ins, equipment start-up, and comprehensive performance qualification (IQ/OQ/PQ) activities.
Maintain strict compliance with GMP, safety protocols, and engineering standards throughout the equipment lifecycle.
Document and manage technical materials, including datasheets, installation drawings, and turnover packages to ensure quality assurance.
Proactively troubleshoot and resolve equipment-related challenges by collaborating with cross-functional teams.
Required Experience & Skills
Demonstrated experience in engineering roles specifically focused on upstream and downstream equipment within the pharmaceutical or biotechnology manufacturing sector.
Solid understanding of bioprocessing systems, cleanroom environments, and GMP compliance best practices.
Hands-on experience with equipment installation, commissioning, and qualification processes.
Familiarity with process utilities and facility integration will be advantageous.
Exceptional coordination, problem-solving, and communication abilities.
Bachelor's degree in Mechanical, Chemical, or Bioprocess Engineering (or a related field).