Instrument Validation Specialist Job at Kelly Services, Lansdale, PA

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  • Kelly Services
  • Lansdale, PA

Job Description

Instrument Validation Specialist – Level I

Primary responsibilities include, but are not limited to:

  • 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 Merck 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.

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.

Requirements:

  • Specialist I focus commensurate with degree and experience requirements
  • Validation: Bachelor’s degree in biological or chemical science and/or engineering plus 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.

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