Validation Engineer II (Contract) Job Pfizer Andover

by admin on more than 30 days

Pfizer Jobs 2020 - Pfizer require the best people to fill Validation Engineer II (Contract) that will be placed in Andover.

Pfizer Jobs 2020

Description :

Instrument Validation Associate

Summary:

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 protocols, resolution of any deviations, and managing the project timeline to ensure timely completion of the validation projects.

Responsibilities:

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 deviations 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

Qualifications:

  • BS engineering or science degree with a minimum of 4+ years of experience or MS engineering or science degree with a minimum 2+ years of experience or equivalent combination of education and experience
  • Experience in validation activities supporting manufacturing and development operating in regulated environment specifically Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)
  • Experience in 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, and assisting with preparation and execution of validation protocols and associated documentation
  • Demonstrated experience with instrument validation and technical writing
  • Proficient in Enterprise systems such as Site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), Empower and/or Chromatographic applications
  • Background in problem solving and experience in project management/support in a matrixed reporting environment
  • Experience in Negotiations, Investigations and Change Control
  • Knowledge of and experience using Data integrity principles

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third party payrolling partner.



For more detail information, please refer official source from Pfizer on following link below :




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