Description

You will manage commissioning, qualification, and validation (CQV) activities for equipment and systems in a pharmaceutical or biopharmaceutical manufacturing environment.

Responsibilities

• Execute CQV activities for plant utilities, clean utilities, HVAC, filling lines, CTUs, component prep equipment, and formulation systems.
• Troubleshoot equipment issues within the manufacturing setting to maintain operational continuity.
• Maintain clear, concise documentation of all validation activities and testing.
• Coordinate tasks and prioritize workflows using project management principles to drive continuous improvement.
• Ensure all validation processes comply with industry regulations and internal quality standards.

Required Skills

• 3-5 years of experience in the CQV field.
• Proven experience in pharmaceutical, biopharmaceutical, or related manufacturing environments.
• Proficiency in commissioning, qualification, and validation processes.
• Hands-on experience with HVAC, filling lines, and CTUs.
• Ability to troubleshoot equipment in a production setting.
• BSc or BEng in Mechanical Engineering, Manufacturing/Industrial Engineering, or an equivalent combination of education and experience.
• Knowledge of Lean and Six Sigma tools for process improvement.
• Strong written and verbal communication skills.

Preferred Skills

• Direct experience in the medical device industry.

Key Skills

Education

Not specified