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Raritan, New Jersey, United States
Onsite
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain EngineeringJob Sub Function:
Repair & Maintenance EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Raritan, New Jersey, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a “Principal Engineer, Vendor Compliance & Asset Performance” to join our team in Raritan, NJ.
Summary
The Principal Engineer, Asset Management & Vendor Compliance Strategy, provides technical leadership for the maintenance, reliability, and compliance of GxP-regulated manufacturing and utility assets at the Raritan site. This role establishes and maintains engineering standards governing vendor-performed services, ensuring work is executed in accordance with site requirements, regulatory expectations, and quality objectives.
The position oversees vendor qualification, compliance, and performance programs while serving as a key technical authority for maintenance, calibration, qualification, and corrective work performed by external service providers. The Principal Engineer collaborates closely with Engineering, Operations, Quality, Procurement, and Legal to develop supplier governance strategies, support Master Service Agreement frameworks, and drive accountability for service delivery across critical assets. Through effective asset lifecycle management and strategic vendor oversight, this role helps ensure reliable equipment performance, regulatory compliance, and achievement of manufacturing and business objectives.
Key Responsibilities
Technical authority over vendor-executed work
Review and approve or reject vendor-authored PM procedures, work instructions, calibration methods, and service reports before that work is executed on GxP assets. Set and maintain the technical acceptance standard.
Act as the site technical escalation point when vendor-executed work contributes to a deviation. Own the vendor-facing portion of the investigation and the resulting CAPA commitments.
Vendor program and commercial structure
Author Scopes of Work that specify technical deliverables, acceptance criteria, and data return obligations rather than labor hours and visit frequency alone.
Define SLAs tied to asset criticality, with response and restoration targets that reflect what a failure costs the manufacturing schedule.
Partner with Procurement and Legal on MSA structure so that technical requirements are carried inside the commercial terms rather than appended to them.
Qualify vendors and contractors against site EHS, GMP, and compliance standards, and maintain qualification status across the contract lifecycle.
Asset data and performance
Standardize the site asset list and asset criticality ranking to support lifecycle planning, PM strategy, and sourcing decisions.
Build and run the vendor performance measurement system: KPI definition, data capture through the CMMS, quarterly business reviews, and documented corrective action when performance falls short.
Route vendor failure and inspection findings back into PM strategy and reliability analysis instead of closing them at the service report.
Own end-of-life and obsolescence strategy for vendor-supported assets, including spare part risk and transition planning.
Capability and site support
Identify work the site currently purchases that it should perform internally and build the business case and transition plan to bring it in-house.
Author and maintain SOPs governing vendor and asset management within Technical Services.
Present vendor performance, asset risk, and program status to site leadership in terms of business consequence, not activity volume.
Qualifications
Education
Minimum of a Bachelor’s degree required. Engineering discipline preferred: Mechanical, Electrical, Chemical, Biomedical, or Industrial.
Required
Minimum 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. You have been accountable for how specific assets perform, not for the administration of the contracts that support them.
Demonstrated authorship or technical approval of PM procedures, qualification protocols, calibration methods, or equipment-related deviations and CAPA.
Working knowledge of GxP requirements as they apply to equipment: qualification lifecycle, change control, data integrity in service records, and regulatory expectations for contracted work performed on GMP assets.
Experience holding external service providers to a technical standard, including rejecting deliverables that do not meet it.
Experience with a CMMS for asset data, work management, and performance reporting. Maximo or SAP PM preferred.
Ability to define KPIs, analyze performance data, and convert the analysis into corrective action.
Strong written and verbal communication. This role authors documents that vendors, Quality, and site leadership all rely on.
Preferred
CMRP or CRL certification.
Cell therapy, autologous manufacturing, or aseptic processing experience.
Experience structuring or negotiating MSAs, SOWs, or service agreements alongside Procurement.
Experience operating within a joint venture, contract manufacturing, or multi-party operating structure.
Green Belt or Black Belt (Lean Six Sigma), or formal problem solving certification.
Other
Requires up to 10% domestic and international travel for vendor site support, audits, and project oversight.
May require standing for extended periods, walking across manufacturing and utility spaces, climbing stairs or ladders, and light lifting of materials or equipment.
Gowning and entry into classified manufacturing space as required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Audit Management, Coaching, Critical Thinking, EHS Compliance, Equipment Maintenance, Lean Supply Chain Management, Manufacturing Standards, Organizing, Performance Measurement, Process Improvements, Quality Control Testing, Quality Validation, Repair Management, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Validation and Qualification Policies, Procedures and Programs
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).