CQV Engineer

Beuningen  ‐ Onsite

Keywords

Good Manufacturing Practices Iq/oq/pq Biotechnology Biology Regulatory Compliance Recruitment Risk Analysis Stakeholder Management Systems Integration Design Documentation Protocol Development

Description

Freelance CQV Engineer - Greenfield Pharmaceutical Project

2 Year Project

We are looking for an experienced Freelance CQV Engineer to support a Greenfield pharmaceutical project. This is an ideal position for an expert looking to contribute to a cutting-edge facility startup.

The ideal professional must be based in the Netherlands.

Responsibilities:
  • Develop and execute commissioning, qualification, and validation plans for project phases.
  • Conduct risk assessments to ensure compliance with cGMP, FDA, and EU regulations.
  • Lead the preparation and execution of IQ/OQ/PQ protocols for systems, utilities, and equipment.
  • Review design documentation and collaborate with project stakeholders on system integration.
  • Troubleshoot and resolve commissioning/validation issues in a timely manner.
  • Generate and maintain detailed technical reports and documentation for regulatory approvals.


Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • Minimum 3 years of CQV experience in the pharmaceutical or biotech industry.
  • Proven track record working on Greenfield projects or facility startups.
  • Expertise in IQ/OQ/PQ protocol development and execution.
  • Familiarity with regulatory guidelines (cGMP, FDA, EU) and validation procedures.
  • Experience with CQV-related software/tools is a plus.
  • English Speaking


Must be based in the Netherlands. If you feel like you could be suited for this then please send your CV to

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
Start date
10.2024
Duration
24 months
From
Darwin Recruitment
Published at
20.09.2024
Contact person:
James Gregory
Project ID:
2798169
Industry
Medicine and Pharmaceuticals
Contract type
Freelance
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