CQV Lead Engineer

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Direct message the job poster from Hamlyn Williams

Specialist Consultant | Automation and Validation Engineering | EU Life Science Contract Recruitment

GMP Warehouse Processing.

We are seeking a skilled professional to lead CQV (Commissioning, Qualification, and Validation) activities, ensuring compliance with internal guidelines and validation plans. This role focuses on the High Bay warehouse (cold and ambient) and key equipment such as visual inspection machines, LAFs, thawing units, cold/freezer rooms, and more. Responsibilities include coordinating execution with CSV and global IT teams, leading C&Q testing with vendors and contractors, developing validation plans, updating master plans, and collaborating with cross-disciplinary teams (HSE, Automation, Engineering, etc.). You’ll also assist the C&Q Lead with the handover and release process.

Skills:

• Bachelor’s or Master’s degree in Mechanical Engineering, Chemical Engineering, or a related discipline
• 8+ years of CQV experience, including High Bay warehouse qualification
• Expertise in authoring CQV lifecycle documents, field CQV execution, and working within cGMP-compliant environments.
• Proficient in Kneat for documentation development, with strong interpersonal, communication, and organizational skills.
• Fluent in English (C1); German is a plus. Proven ability to work independently under pressure and meet strict deadlines.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Pharmaceutical Manufacturing

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