Metrology Specialist I On-site in West Point PA
Summary: - 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.
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