Aseptic DP Process Engineering Leader

Johnson & Johnson Innovation; Wilson (NC); On-site; Confidential; Full time

Job summary

Johnson & Johnson seeks a Sr. Principal Engineer, Process Engineering System Owner – Aseptic DP Compounding in Wilson, NC.

You will lead end-to-end process engineering for aseptic drug product compounding, partnering with manufacturing, facilities, MSAT, quality, procurement, and external vendors to deliver compliant, scalable solutions. You will own design, qualification, commissioning, and start-up of compounding suites, ensuring regulatory alignment and project success in a dynamic biomedical

Qualifications

• Minimum 10 years in aseptic drug product compounding in a biotherapeutics cGMP environment.
• Strong partnerships with key stakeholders.
• Experience designing and implementing single-use technology and stainless steel tanks.
• Lead and coordinate cross-functional teams and external partners.

Responsibilities

• Develop and deliver aseptic, biotherapeutic drug product compounding equipment specifications and drawings (single-use mixers, stainless steel tanks, COP/SOP skids, data sheets, P&IDs, PFDs).
• Lead FAT, SAT, C&Q and start-up activities for compounding suites.
• Direct commissioning, qualification, and start-up efforts; ensure regulatory compliance and readiness.
• Drive process engineering design for two aseptic DP compounding suites and collaborate with vendors and multi-functional teams.
• Mentor teams, manage cross-functional partners, and drive project schedules and execution.

Skills

Aseptic process engineering

Project leadership

Stakeholder collaboration

Problem solving

Regulatory compliance (cGMP)

Education

Bachelor's degree in engineering (Chemical preferred)

MS or MBA preferred

Job description

Johnson & Johnson seeks a Sr. Principal Engineer, Process Engineering System Owner – Aseptic DP Compounding in Wilson, NC.

You will lead end-to-end process engineering for aseptic drug product compounding, partnering with manufacturing, facilities, MSAT, quality, procurement, and external vendors to deliver compliant, scalable solutions. You will own design, qualification, commissioning, and start-up of compounding suites, ensuring regulatory alignment and project success in a dynamic biomedical