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About Innovative Medicine

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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.

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