Job Description

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**

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