CQV Engineer

Sligo Based Role GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a CQV Engineer for our Sligo based client. CQV - Pharma Manufacturing Job Summary: We are seeking a highly motivated and experienced CQV (Commissioning, Qualification, and Validation) professional to join our Pharma Manufacturing team. The successful candidate will be responsible for leading and executing CQV activities for pharmaceutical manufacturing equipment, systems, and facilities, ensuring compliance with cGMP regulations and industry best practices. This role is critical in bringing new or modified assets into validated operational status. Key Responsibilities: Lead and execute commissioning, qualification (IQ/OQ/PQ), and validation activities for manufacturing equipment, utilities, and systems (e.g., HVAC, purified water, clean steam, process equipment, automation). Develop and review CQV documentation, including URS, FDS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports. Manage deviations, non-conformances, and change controls related to CQV activities, ensuring timely resolution and documentation. Collaborate cross-functionally with Engineering, Manufacturing, Quality Assurance, and Regulatory Affairs teams. Provide technical expertise and guidance on cGMP, GAMP 5, and other relevant regulatory requirements. Oversee and coordinate vendor activities for equipment installation and testing. Participate in regulatory inspections and internal audits, providing necessary documentation and support. Mentor junior CQV engineers and contribute to the continuous improvement of CQV processes. Qualifications: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific discipline. Proven experience with cGMP, FDA, EMA, and other relevant regulatory guidelines. Demonstrated ability to review, and approve CQV documentation. Excellent problem-solving, analytical, and communication skills. Ability to work independently and as part of a multidisciplinary team. #Gertek To start the process click the Continue to Application or Login/Register to apply button below.