We are seeking an experienced CQV Engineer to support ongoing site operations and upcoming projects. This role will be responsible for commissioning, qualification, and validation activities across process equipment, filling and packaging lines, and utility systems. The ideal candidate will have a solid background in pharmaceutical manufacturing and a practical understanding of CQV principles within regulated environments.
Key Responsibilities
* Plan, coordinate, and execute CQV activities for new and existing process, fill/pack, and utility systems.
* Develop and execute qualification protocols (IQ/OQ/PQ) in compliance with GMP and site standards.
* Support start-up and validation of bulk formulation, filling, and packaging equipment.
* Liaise with cross-functional teams including Engineering, Manufacturing, and Quality to ensure project deliverables are met.
* Prepare and maintain all CQV documentation, ensuring alignment with corporate and regulatory requirements.
* Participate in risk assessments, change control, and deviation management related to equipment and systems.
* Support continuous improvement initiatives and contribute to maintaining a culture of compliance and quality excellence.
Candidate Requirements
* Bachelor's degree in Engineering, Science, or a related technical discipline.
* Minimum 5 years' experience in the pharmaceutical industry.
* Strong CQV experience with Process Equipment (Filling/Packing an advantage) and Utility systems.
* Demonstrated knowledge of GMP, validation lifecycle, and regulatory compliance.
* Excellent communication, documentation, and problem-solving skills.
* Ability to work collaboratively in a cross-functional team environment