Instrument Validation Specialist

Job Title: Instrument Validation Specialist

Job Location: 770 Sumneytown Pike, West Point, PA 19486

Onsite Requirements:

• 2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification)


• Direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).


• Ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

Job Description:

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.


• 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:

• 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.

• **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**