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Senior Validation Engineer

5 months ago

Minneapolis, United States EPM Scientific Full time

EPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, Minnesota

This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

  • Oversee validation and quality engineering for internally manufactured products
  • Lead CAPA/NCR/SCAR investigations and reports
  • Manage validation standard operating procedures in compliance with regulatory requirements
  • Develop validation plans, protocols, and reports for assembly and packaging processes
  • Design for Six Sigma and Critical to Quality training and experience a plus
  • Support internal and external audits

Experience:

  • 5-7 years of relevant experience within the medical device industry or related function
  • Lead auditor certification preferred
  • Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus

Contract details:

  • 6 months
  • 40 hours
  • W2 contract
  • Anticipated Start: ASAP