Metrology Specialist

Metrology Specialist I

On-site in West Point PA

• Manage equipment assets at multiple locations
• Gain a working knowledge of laboratory equipment to facilitate troubleshooting and communicate with vendors or service engineers 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
• Maintain a customer‑focused mindset with the ability to communicate adequately (verbally and in writing) to all levels within the organization
• Show willingness and ability to quickly upskill in Merck facilities/instrument support programs such as SAP, Pro Cal, BAS, LAMP, electronic validation, and other document or asset repositories
• Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment
• Support the purchase, installation, and equipment qualification of new laboratory equipment

• Prepare, review, and approve archived instrument/equipment documentation such as master equipment lists, user access reviews, instrument installation and 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

• There will be training opportunities to support validation activities
• Support primarily the qualification/validation of computerized analytical systems as per current guidelines
• Partner with the business unit in 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
• Possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus)
• 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