Senior Manufacturing Process Engineer

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

A leading biopharma manufacturer is seeking a Senior Principal Process Engineer to lead the design, implementation, commissioning, qualification, and start-up of equipment preparation systems within a new cGMP manufacturing facility.

This role will serve as the SME for:

• Autoclaves
• Parts Washers
• COP & SOP Systems
• Filter Integrity Testing
• Equipment Preparation & Assembly Processes

Key Requirements:

• Minimum 10+ years' experience in process engineering and/or capital project delivery within pharmaceutical or biologics manufacturing.
• Hands-on expertise with autoclaves, parts washers, COP/SOP systems, and aseptic manufacturing equipment.
• Experience leading FAT, SAT, Commissioning & Qualification (C&Q), and facility start-up activities.
• Strong knowledge of FDA cGMP, EU GMP Annex 1, and aseptic manufacturing requirements.
• Proven ability to manage vendors, engineering firms, and cross-functional stakeholders on large-scale capital projects.

Preferred

• Greenfield or brownfield GMP facility start-up experience
• Capital project leadership within biologics or sterile manufacturing
• Experience supporting projects valued between $100M-$500M

This is a unique opportunity to play a key role in the delivery of a major biologics manufacturing facility and influence its transition from design through operational readiness.

Location & Travel

The position will initially be based in Conshohocken, Pennsylvania, working closely with project and engineering teams during the design and execution phases of the facility. Following the first year, the role will transition to Wilson, North Carolina, where the successful candidate will support commissioning, qualification, start-up, and ongoing operations. Full travel expenses will be covered by employer.

Open to Relocating candidates. Must have full right to work - Unable to sponsor.