Instrument Validation Specialist Job at Softworld, a Kelly Company, West Point, PA

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  • Softworld, a Kelly Company
  • West Point, PA

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**

Job Tags

For subcontractor,

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