CQV

Job Title: Freelance CQV Engineer
Start Date: January 2025
Contract: 12 Months
Location: Denmark

I am working with a big pharma company and looking for an experienced CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing systems, utilities, and equipment. The ideal candidate will have 5-10+ years of experience in CQV within Downstream processes and mAb processes,

Key Responsibilities:

• Lead CQV activities for manufacturing systems (HVAC, water, production equipment).
• Develop and review IQ, OQ, PQ protocols and reports.
• Collaborate with engineering, quality, and manufacturing teams.
• Ensure compliance with FDA, EU GMP, and internal SOPs.
• Troubleshoot CQV issues and implement corrective actions.
• Maintain cGMP-compliant documentation and conduct risk assessments.

Requirements:

• 5-10+ years in CQV, with experience in Downstream and mAb processes.
• Strong regulatory knowledge (FDA, EU GMP).
• Excellent documentation, problem-solving, and team collaboration skills.

If you're interested, please share a time to discuss further!