Validation Engineer - Medical Device

Location: Minneapolis, Minnesota, United States
Salary: medical, dental, vision, 401K
Sectors: Operations
Job Type: Contract
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The Process Validation Engineer will be responsible to lead the retrospective review of the process validation of molds and equipment. The candidate will identify process validation gaps, implement appropriate GMP solutions to correct them and develop the Master Validation Plan. This candidate must have the skills set to write, execute, compile data and report on equipment IQ/OQ validation protocols. The Process Validation Engineer must be an expert in the validation and commission of Molds and different equipment's used in cGMP manufacturing processes.

Responsibilities Include:

  • Retrospective review of process validation for all the equipment.
  • Identify gaps found in the equipment's process validation.
  • Will create reports for the remediation work stream management.
  • Will perform IQ, OQ and PQ execution
  • Close gaps found and implement effective preventive measures.
  • Develop the Master Validation Plan.

Educations/ Experiences:

  • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline
  • 5+ years pharmaceutical or medical devices process validation experience
  • Thorough knowledge of cGMP / FDA regulations 21CFR210/211 and Section 820
  • Thorough knowledge of cGMPs and internal SOPs related to Process Validation.

Sthree US is acting as an Employment Business in relation to this vacancy.

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