Senior Principal Biopharma Process Engineer — C&Q & Start-up

Blackfield Associates; Wilson (NC); On-site; USD 170,000 - 230,000; Full time

Job summary

Blackfield Associates is seeking a Senior Principal Process Engineer to lead design, implementation, commissioning, qualification, and start-up of equipment preparation systems for a new cGMP biopharma facility. The role will initially be based in Conshohocken, PA, with a transition to Wilson, NC as operations commence.

You will act as SME for autoclaves, parts washers, COP/SOP systems and aseptic manufacturing, while guiding vendors and cross-functional teams on multi-hundred million dollar

Qualifications

• Minimum 10+ years in process engineering and/or capital project delivery in pharmaceutical or biologics manufacturing.
• Hands-on experience with autoclaves, parts washers, COP/SOP systems, and aseptic equipment.
• Experience leading FAT, SAT, C&Q and facility start-up activities.
• Strong knowledge of FDA cGMP, EU GMP Annex 1, and aseptic manufacturing requirements.

Responsibilities

• Lead the design, implementation, commissioning, qualification and start-up of equipment preparation systems for a new cGMP facility.
• Serve as SME for autoclaves, parts washers, COP/SOP systems, and aseptic equipment; coordinate with vendors and cross-functional teams.
• Manage multi-site capital projects and ensure compliance with regulatory standards throughout all phases of design and start-up.

Skills

Process engineering

Capital project delivery

GMP compliance

Aseptic manufacturing

Vendor management

Job description

Blackfield Associates is seeking a Senior Principal Process Engineer to lead design, implementation, commissioning, qualification, and start-up of equipment preparation systems for a new cGMP biopharma facility. The role will initially be based in Conshohocken, PA, with a transition to Wilson, NC as operations commence.

You will act as SME for autoclaves, parts washers, COP/SOP systems and aseptic manufacturing, while guiding vendors and cross-functional teams on multi-hundred million dollar