Sr. Principal Engineer, Equipment Preparation Lead
Johnson & Johnson
Wilson, North Carolina, United States of America
Fully remote
Equipment preparation system design
Cgmp aseptic manufacturing compliance
Commissioning and qualification leadership
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation
Job Summary
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
The Sr. Principal Engineer, Equipment Preparation Lead will be accountable for end-to-end process engineering leadership in equipment preparation for a new cGMP drug product manufacturing plant.
This role requires frequent travel (>75%) during the design phase and full-time onsite presence in Wilson, North Carolina during plant start-up.
Matching Summary
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
Skills & Requirements
Must-have
Equipment preparation system design
cGMP aseptic manufacturing compliance
Commissioning and qualification leadership
Process engineering for autoclaves and parts washers
Cross-functional team collaboration
Vendor competency assessment and management
Nice-to-have
Agile decision making
Coaching and consulting skills
Disruptive innovations
Lean supply chain management
Technical research
Program and project schedule management
Key Requirements
Minimum 10 years process engineering experience
Bachelor's degree in engineering required; MS or MBA preferred
Extensive experience with autoclaves, parts washers, COP/SOP, filter integrity testing
Strong knowledge of cGMP regulations including EU Annex 1
Experience leading capital projects in aseptic processing
Ability to lead multicultural teams and remote customers