Job Description

Title: Specialist, Analytical Metrology & Validation, Global Quality Large Molecule Analytical Science

The Global Quality Large Molecule Analytical Science (GQLMAS) department of our company's Manufacturing Division is seeking applicants for a specialist to support metrology and validation team at the West Point and North Wales, PA facility. 

The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs. This role required working with a team of metrology and equipment coordination supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP and non-GMP environment.

The key responsibilities of this role will include:

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 our 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 Focus:

• 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.

Education Minimum Requirements (standard for each level) 

• HS Diploma/GED with working experience

• Bachelor’s degree in biological or chemical science Preferred

• 4+ years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification,

Required Experience and Skills 

• Perform and direct team validation activities as an independent author

• Highly skilled in operating analytical computerized instrumentation within a pharmaceutical or equivalent laboratory.

• Collaborate independently with various project teams and execute tasks efficiently

• Financial