What are the responsibilities and job description for the CQV Engineer position at Efor Group?
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.