Senior Principal Process Engineer - Aseptic Filling Systems

Blackfield Associates

Wilson (NC)

On-site

USD 180,000 - 260,000

Full time

9 hours ago

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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

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

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