Instrument Validation Specialist/ Metrology Specialist I - Softworld, a Kelly Company : Job Details

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**