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 is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Location: 100% On-site in Rahway, NJ

• Manage equipment assets at multiple locations

• Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the 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 the ability to communicate adequately (verbally/writing) to all levels within the organization.

• Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, ProCal, 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.

Calibration Focus:

• Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification 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.

*** There will be training opportunities to support Validation*** 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.

General Requirements Level 1:
Bachelor's degree in biological or chemical science and/or engineering plus

• 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.