Senior Manufacturing Process Engineer at Blackfield Associates Senior Manufacturing Process Engineer at Blackfield Associates in Black Creek, North Carolina Posted in about 15 hours ago.

Type:

full-time 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 c

GMP, 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.