Instrument Validation Specialist

Metrology Specialist I

Kelly Science and Clinical FSP is currently seeking a Metrology Specialist for a long-term engagement in Rahway, NJ with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and offers full benefit options, including Medical, Dental, Vision, 401K, and paid time off (holiday, vacation, sick/personal time).

100% On-site in Rahway, NJ

• Manage equipment assets at multiple locations
• Gain a working knowledge of laboratory equipment to facilitate troubleshooting and communicate with vendor/service engineer to identify resolutions
• Participate in computer system validation activities associated with new or upgraded equipment or software packages
• Originate and progress deviations and change control records
• Perform and document investigations and assist in developing and implementing CAPA plans
• Contribute to new SOP drafting, implementation, and revisions
• Represent the laboratory on all aspects of laboratory equipment during audits
• Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures
• Customer focused mindset with ability to communicate adequately (verbally and in writing) to all levels within the organization
• Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, Pro Cal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
• Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment

• Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, I/Q documentation, and calibration documentation
• Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships
• Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross‑training and cross‑site support
• Support the purchase, installation, and equipment qualification of new laboratory equipment

Validation activities are included below.

• Support primarily the qualification/validation of computerized analytical systems as per current guidelines
• Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers
• Perform any required change control during the life cycle of a computerized system
• Decommission systems as required as part of the equipment qualification/validation life cycle
• Manage the capital purchasing and initial installation of computerized analytical systems prior to validation
• Participate in various data integrity and lab modernization activities as required
• Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus)
• Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system

• Bachelor’s degree in biological or chemical science and/or engineering
• 2–4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification)
• Experience working in a GMP environment and maintaining laboratory equipment
• Highly organized, strong communication skills
• Capable of working independently
• Solutions orientated mindset with the ability to handle multiple high‑priority tasks at one time
• Ability to succeed in a dynamic environment; flexibility to respond to changing priorities
• Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment

This is a long-term engagement, full-time, with comprehensive benefits. Contact Kelly Science and Clinical FSP for more information.