Instrument Validation Associate

  • location: Andover, MA
  • type: Contract
  • salary: $75 - $100 per hour
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job description

Instrument Validation Associate

job summary:
Great Client in the Greater Boston Area is looking for a Instrumentation Validation Specialist. Needs to have experience with in the area of validation activities supporting manufacturing and development operating in regulated environment. Must have strong experience with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)

location: Andover, Massachusetts
job type: Contract
salary: $75 - 100 per hour
work hours: 9am to 6pm
education: Bachelors
  • Authoring validation documentation (validation plans, requirement specifications, IOPQ protocols, validation summary reports) for analytical and microbiology instrumentation
  • Participating in Data Integrity and Electronic Records and Electronic Signatures assessments for instrumentation during the validation process
  • Execution of qualification protocols
  • Resolution of devitations encountered during validation projects
  • Managing validation project timelines
  • Additional activities associated with the validation life cycle for GMP instrumentation

  • 4+ years experience
  • Management of HPLC Instrumentation, scheduling routine and non-routine maintenance activities
  • Performance Verification of HPLC Instrumentation
  • Preparing Periodic Review documentation
  • Decommissioning instrumentation no longer required for GMP operations
  • Assistance with preparation and execution of validation protocols and associated documentation

  • Quality, CFR 211, Pharma Validation,

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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