Job Details

Project Engineer - Pharmaceutical Manufacturing

  2025-09-11     Blackfield Associates     Sonoma,CA  
Description:

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).


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