CQV Engineer

About the Role:

We are seeking a highly motivated and experienced CQV Engineer with a strong background in pharmaceutical filling lines to join our team. The CQV Engineer will lead and execute commissioning, qualification, and validation activities for primary and secondary packaging/filling equipment in compliance with GMP and regulatory requirements.

Key Responsibilities:

• Plan, develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for pharmaceutical filling line equipment and systems.
• Oversee equipment installation, start-up, and troubleshooting, ensuring adherence to project timelines and quality standards.
• Collaborate with engineering, QA, manufacturing, and project teams to support system integration, process optimization, and regulatory compliance.
• Prepare and review technical documentation, including URS, functional/design specifications, risk assessments, FAT/SAT protocols, change controls, and reports.
• Ensure all activities comply with company SOPs, GMP standards, and international regulatory requirements (FDA, EMA, etc.).
• Lead investigations into deviations, nonconformances, and CAPA related to qualification and validation activities.
• Support project management efforts in the planning and execution of filling line modification, expansion, or new build projects.
• Provide technical expertise and training on validation/qualification processes for engineering and production teams.

Requirements:

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, or related technical field.
• 3+ years’ direct experience in CQV within the pharmaceutical industry, specifically with automated filling and packaging lines (aseptic and/or non-aseptic).
• Proven expertise in writing and executing validation lifecycle documents (IQ/OQ/PQ).
• Strong understanding of GMP, FDA, and EMA regulations as they relate to facility and equipment qualification.
• Experience with risk management, change control, deviation management, and root cause analysis.
• Excellent verbal and written communication skills.
• Ability to work independently and in cross-functional teams.