Senior Equipment Preparation & Process Engineering Lead

Johnson & Johnson Innovative Medicine; North Carolina; On-site; USD 165,000 - 230,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Principal Engineer, Equipment Preparation Lead, to lead the end-to-end equipment prep area for a new cGMP drug product manufacturing plant.

Based in Wilson, NC, you will guide design, commissioning, qualification, and start-up activities, partnering with Manufacturing, Facilities, Quality, and external vendors to ensure regulatory compliance and project success. You will apply deep process engineering expertise to resolve complex technical challenges, drive

Qualifications

• Minimum 10 years in process engineering or capital projects for equipment prep (autoclaves, parts washers, filter integrity testing, COP/SOP, disassembly/assembly).
• Strong partnerships with stakeholders and remote/multicultural teams.
• Experience with external partners (A&E, construction firms, equipment vendors).
• Understanding of cGMP for aseptic manufacturing and EU/FDA regulations.

Responsibilities

• Develop equipment prep area system specs, data sheets, P&IDs, and drawings.
• Lead design and development with cross-functional teams and vendors.
• Direct FAT, SAT, C&Q, and start-up activities; resolve issues during C&Q.
• Ensure regulatory compliance and alignment with evolving business needs.
• Drive process engineering innovations and maintain technical knowledge across the team.

Skills

Process engineering

Capital project execution

Leadership

Vendor management

C&Q

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree in engineering

MS or MBA preferred

Job description

Johnson & Johnson is seeking a Sr. Principal Engineer, Equipment Preparation Lead, to lead the end-to-end equipment prep area for a new cGMP drug product manufacturing plant.

Based in Wilson, NC, you will guide design, commissioning, qualification, and start-up activities, partnering with Manufacturing, Facilities, Quality, and external vendors to ensure regulatory compliance and project success. You will apply deep process engineering expertise to resolve complex technical challenges, drive