Validation Engineer

  • location: Andover, MA
  • type: Contract
  • salary: $50 - $60 per hour
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job description

Validation Engineer

Contract position: Global leader in the medical product manufacturing industry is currently looking for Validation Engineer in Andover MA to implement and maintain various equipment systems in support of the manufacture of clinical biologic drug products. This is a contract position expected to last 12 months, possible extension, possible temp to hire. Great Contractor Benefits! Apply Now!

Responsibilities for the Validation Engineer
  • Validation support for the execution of IOPQs and RQs to enhance or sustain critical process equipment being utilized by the LDM on a daily basis
  • Drafting technical reports, processing documents for approval and schedule of qualification activities
  • Manage the qualification effort i.e. coordination of materials and equipment
  • Generate all necessary electronic protocols for the breadth of the qualification effort. This includes drafting, reviewing, receipt and addressing of comments, and securing approvals
  • Own and execute equipment commissioning and qualification activities
  • Traditional validation approaches will be used for the equipment (Commissioning, IQ, OQ, PQ)
  • Generate all necessary electronic summary reports required for the efforts above. This includes drafting, reviewing, receipt and addressing of comments, and securing approvals
Requirements for the Validation Engineer

  • Bachelor Degree in Engineering
  • 5+ years of GMP equipment validation
  • GMP Aseptic experience
  • Commissioning, IQ, OQ, PQ is a must
  • GMP experience is a must
  • Extensive knowledge of computer system validation
Benefits

  • Paid Vacation
  • 401K
  • Health Insurance, and more...
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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