Lead Principal Process Engineer, Aseptic Filling Systems

jj; Charlotte (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine unit in Wilson, NC seeks a Sr. Principal Process Engineer to lead end‑to‑end aseptic filling line systems (vials and prefilled syringes) from concept through qualification and start‑up.

The role requires a Bachelor's degree in engineering and 10+ years of process engineering experience in a cGMP environment, with SME leadership across Manufacturing, MSAT, Quality, Facilities, and external partners.

Qualifications

• Bachelor's degree in engineering required.
• Minimum 10 years in process engineering for aseptic filling systems.
• Experience as SME for aseptic filling of sterile biologics.
• Hands-on design, installation, qualification (C&Q) and start-up.
• In-depth knowledge of FDA cGMPs and EU Annex 1.

Responsibilities

• Lead end-to-end aseptic filling line system documentation and specs.
• Evaluate vendors, review bids, and drive technical discussions.
• Design and engineer filling line equipment with cross-functional teams.
• Own layout and integration of filling line within the facility.
• Lead FAT, SAT, C&Q, and start-up activities.
• Resolve technical issues during C&Q and start-up phases.
• Coordinate across Manufacturing, Quality, Facilities, EHS, andProcurement.
• Provide technical leadership and partner management across teams.
• Stay current with industry trends, regulations, and benchmarks.
• Apply data-driven insights to optimize system performance.

Skills

Process engineering

Aseptic filling

SME leadership

Regulatory compliance

Cross-functional collaboration

Vendor management

Education

Bachelor's Degree in Engineering

Job description

Johnson & Johnson's Innovative Medicine unit in Wilson, NC seeks a Sr. Principal Process Engineer to lead end‑to‑end aseptic filling line systems (vials and prefilled syringes) from concept through qualification and start‑up.

The role requires a Bachelor's degree in engineering and 10+ years of process engineering experience in a cGMP environment, with SME leadership across Manufacturing, MSAT, Quality, Facilities, and external partners.