Principal Engineer, Vendor Compliance & Asset Performance (GxP)

Location: Raritan, New Jersey, United States of America; on-site work involving manufacturing and utility spaces, with up to 10% domestic and international travel

Base pay: $102,000–$177,100 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including products and services supporting treatment and manufacturing.

What you will do

• Provide technical authority for vendor-performed maintenance, calibration, qualification, corrective work, and service reporting on GxP assets.
• Define scopes of work, technical acceptance criteria, service-level agreements, and vendor governance requirements with Procurement and Legal.
• Qualify external service providers against EHS, GMP, and site compliance standards throughout the contract lifecycle.
• Standardize asset data and criticality rankings, and operate vendor performance measurement through CMMS data, KPIs, reviews, and corrective actions.
• Feed vendor failures and inspection findings into preventive maintenance and reliability strategies, including end-of-life, obsolescence, spare-parts, and transition planning.
• Develop SOPs, business cases, and transition plans for bringing selected outsourced work in-house; present asset risk and vendor performance to site leadership.

Requirements

• Bachelor’s degree required; Mechanical, Electrical, Chemical, Biomedical, or Industrial Engineering preferred.
• At least 6 years of engineering experience in GMP pharmaceutical, biologics, or cell and gene therapy manufacturing.
• Direct technical ownership of manufacturing or utility equipment in a regulated environment.
• Experience authoring or technically approving PM procedures, qualification protocols, calibration methods, equipment deviations, or CAPA.
• Working knowledge of GxP equipment requirements, qualification lifecycles, change control, service-record data integrity, and contracted GMP work.
• Experience with CMMS-based asset and work management, performance reporting, KPI analysis, and holding service providers to technical standards; Maximo or SAP PM preferred.

Nice to have

• CMRP or CRL certification.
• Cell therapy, autologous manufacturing, or aseptic processing experience.
• Experience structuring or negotiating MSAs, SOWs, or service agreements with Procurement.
• Joint venture, contract manufacturing, or multi-party operating experience.
• Lean Six Sigma Green Belt or Black Belt, or formal problem-solving certification.

Culture & Benefits

• Inclusive work environment focused on healthcare innovation and patient impact.
• Retirement pension and 401(k) savings plans, subject to plan terms.
• Vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
• Work includes gowning and entry into classified manufacturing spaces as required, along with standing, walking, climbing stairs or ladders, and light lifting.