Job Description
Job Title : Instrument Validation Specialist/ Metrology Specialist I
Job Location: 770 Sumneytown Pike, West Point, PA 19486
Onsite Requirements:
- 2-4 years of experience participating in metrology elements- preventative maintenance/calibration/ onboarding/decommissioning of laboratory equipment
- GMP Experience
- Significant experience working within the Microsoft office suite of software (strong professional communication skills- written and verbal)
Job Description:
Job Responsibilities:
- 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 Client 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
Validation Support:
- 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
Requirements Level:
- 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
- **3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.
- This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future**
Job Tags
For subcontractor, Work at office,