Onsite with frequent travel (> 75%) until project transition.
Aseptic manufacturing node design
Cgmp and industry standards compliance
Process engineering specifications development
Johnson & Johnson is seeking a Director of Aseptic Drug Product Process Engineering to lead the technical aspects of a new aseptic manufacturing facility in Wilson, North Carolina. The ideal candidate will have extensive experience in biotherapeutics within a cGMP environment, strong leadership skills, and a proven track record in process engineering
Job Summary
The Director, System Owner Lead will provide overall E2E process engineering leadership to equipment and facility design of a new DP aseptic manufacturing node, ensuring efficient design and operational readiness.
Key responsibilities include developing process engineering specifications, assessing vendor capabilities, resolving technical issues during C&Q testing, and ensuring alignment across multiple business functions.
The role requires cultivating a culture of technical excellence, collaboration, and innovation, while developing and mentoring engineering team members.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Director of Aseptic Drug Product Process Engineering to lead the technical aspects of a new aseptic manufacturing facility in Wilson, North Carolina. The ideal candidate will have extensive experience in biotherapeutics within a cGMP environment, strong leadership skills, and a proven track record in process engineering.
Skills & Requirements
Must-have
aseptic manufacturing node design
cGMP and industry standards compliance
process engineering specifications development
vendor competency assessment
technical issue resolution
cross-functional collaboration
Nice-to-have
inclusive work environment
technical excellence culture
data-driven insights
industry trend benchmarking
Key Requirements
Bachelor's Degree in Engineering (Mechanical or Chemical preferred)
15+ years in biotherapeutics cGMP drug product experience
5+ years of people leadership experience
Experience with EU, FDA cGMPs and EU Annex 1 guidelines
Experience with EHS requirements and EHS by design
Experience with start-up processes and Commissioning & Qualification