Senior CQV / Validation Engineer

Senior CQV / Validation Engineer.

Senior CQV / Validation Engineer

Wisconsin

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Contract

|

CQV

We are urgently seeking an experienced CQV / Validation Engineer for a pharmaceutical manufacturing site in Wisconsin.

The responsibilities for this role include but are not limited to:

Project Management:

  • Oversee multiple projects/clients.
  • Act as primary contact and escalation point for clients.
  • Ensure project schedule adherence.

Validation Planning and Execution:

  • Design validation plans and engineering studies.
  • Author, edit, and execute validation documentation.
  • Run test scripts, document results, and recommend design/process modifications.
  • Conduct user interface, software verification, and alarm testing on automated systems.

Technical Oversight:

  • Verify P&IDs, I&C drawings, and electrical schematics.
  • Conduct and document impact and risk assessments.
  • Maintain detailed records for compliance audits.

Collaboration and Communication:

  • Work with equipment OEMs and installation vendors.
  • Communicate requirements to different client levels.

Documentation and Compliance:

  • Develop and execute testing documentation.
  • Understand and use URS, IQ, OQ, PQ documents.

Requirements

Experience:

  • 5-7 years in CQV within GMP environments.
  • Experience with reactors, dryers, powder handling, clean rooms, support facilities, and tank farms.
  • Authoring/executing FAT, SAT, IOQ, CSV protocols.

Technical Skills:

  • Proficient in WORD; basic skills in EXCEL and PowerPoint.
  • General knowledge of capital equipment and process implementation.

Personal Attributes:

  • Strong communication, attention to detail, and organizational skills.
  • Ability to work independently.
  • Onsite work.
  • GMP and Good Documentation Practice training (onboarding possible).

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

Greg King

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