Job Details

  • Title: Instrument Validation Associate
  • Code: RCI-19790-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 10/20/2020
  • Duration: 9 Months
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  Job Description

  • The Instrument Validation Specialist will support a diverse variety of Quality Control and Manufacturing Instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle.
  • This role will be responsible for developing validation documentation, including validation plans, requirement specifications, IOPQ protocols, and validation summary reports, execution of validation protools, resolution of any deviations, and managing the project timeline to ensure timely completion of the validation projects.

The primary position responsibilities are listed below:

  • 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

This position will regularly interact with:

  • Quality Control
  • Quality Assurance
  • Andover Production Operations
  • Engineering Validation and Maintenance
  • Site Technical Services
  • Business Technology
  • Other groups as applicable

The required experience is in the area of validation activities supporting manufacturing and development operating in regulated environment. 
Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)

Experience also required:

  • Background in problem solving
  • Negotiations
  • Data integrity principles
  • Project management/support in a matrixed reporting environment
  • Investigations and Change Control experience
  • 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
  • Experience with instrument validation
  • Technical writing
  • Skilled at the use of Enterprise systems including, but not limited to:
    • Site Quality Tracking System (QTS)
    • Laboratory Information Management System (LIMS)
    • Empower and/or Chromatographic applications