Senior Lead Process Engineer

Blackfield Associates; Wilson (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Blackfield Associates seeks a Senior Principal Process Engineer in Wilson, NC to provide technical leadership for aseptic filling systems from concept through commercial readiness. The role covers vial and pre-filled syringe filling, isolators and related aseptic processing equipment, with significant travel during the project phase.

The candidate should have extensive experience in aseptic filling within biopharma, strong regulatory knowledge, and a track record of delivering complex capital

Qualifications

• 10+ years in aseptic filling process engineering or capital projects in biopharma.
• Expertise in sterile biologics (mAbs, recombinant proteins, vaccines).
• Experience leading design, installation, commissioning and start-up of aseptic lines and isolator tech.
• Strong knowledge of FDA cGMP, EU GMP Annex 1, contamination control and aseptic processing.
• Experience managing vendors, partners and cross-functional stakeholders.

Responsibilities

• Lead design, installation, commissioning, qualification and start-up of aseptic filling systems.
• Oversee rollout of vial and pre-filled syringe filling technologies and isolators.
• Coordinate with vendors and internal teams to ensure regulatory readiness and project milestones.

Skills

Aseptic filling

Capital project delivery

Regulatory knowledge

Stakeholder management

Education

Bachelor's degree in Engineering

Job description

Senior Principal Process Engineer - Aseptic Bio therapeutic Filling Equipment

Wilson, North Carolina (On-site) | Significant travel during project phase

Blackfield Associates are supporting a leading biopharmaceutical manufacturer, who due to project demands are seeking a Senior Principal Process Engineer to provide technical leadership for the design, implementation, commissioning, qualification, and start-up of next-generation aseptic filling systems supporting a major cGMP manufacturing facility.

This is a high-impact SME role responsible for delivering vial and pre-filled syringe filling technologies, isolators, E-beam systems, and associated aseptic processing equipment from concept through commercial readiness.

Key Requirements

• 10+ years' experience in aseptic filling process engineering and/or capital project delivery within a biopharmaceutical manufacturing environment
• Expertise in sterile injectable biologics, including monoclonal antibodies, recombinant proteins, vaccines, or related products
• Proven experience leading design, installation, commissioning, qualification (C&Q), and start-up of aseptic filling lines and isolator-based technologies
• Strong knowledge of FDA cGMP regulations, EU GMP Annex 1, contamination control strategies, and aseptic processing
• Experience managing major equipment vendors, engineering partners, and cross-functional stakeholders
Demonstrated success delivering complex capital projects, ideally within greenfield or brownfield manufacturing facilities

Preferred:

• Experience leading aseptic filling projects valued at $50M-$80M
• Strong technical leadership and stakeholder management skills
• Bachelor's degree in Engineering (Mechanical preferred); advanced degree advantageous

This is an outstanding opportunity to play a key role in developing a world-class biopharmaceutical manufacturing operation and shaping the future of sterile drug product manufacturing.