Job Details

  • Title: Validation Engineer
  • Code: RCI-9599912
  • Location: Framingham Massachusetts (MA) 01701
  • Posted Date: 12/03/2019
  • Duration: 8 Months
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  Job Description

Duties:

  • Perform validation projects in a GMP biotech manufacturing facility.
  • Develop/plan qualification/validation studies, execute, compile data, and author reports
  • Resolve protocol nonconformances.
  • Knowledge of risk-based validation approaches that meet current regulatory requirements, internal standards and industry practices.
  • Complete all internal training.
Skills:
  • Demonstrated success working across organizations in highly matrixed/team environment.
  • Proficient in use of GE/Kaye Validator as applicable.
  • Experience with validation of GMP manufacturing equipment and utilities, e.g., WFI, compressed gases, HVAC, controlled temperature units
  • Familiarity with applicable US and worldwide regulatory requirements.
  • Ability to read/interpret engineering drawings and design documents..
  • Excellent technical writing and verbal communication skills.
  • Proficiency in Microsoft Office including Word and Excel
  • Knowledge of Validation Lifecycle Approach.
Experience:
  • plus previous experience in CQV field or equivalent experience.
  • Experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
  • Areas of experience: CQV of GMP manufacturing equipment, including requalification.