CQV Engineer - Formulation & Component Preparation
Dublin, Ireland (Onsite)
Contract: 12 months
Must-Have Equipment Experience
Specifically experience with CQ of Single Use Mixers & TCUs, Utility Panels & Filtration Systems (TFF), Autoclaves, Parts Washers and Powder Handling equipment such as Blenders and Jet Mills.
Join our team as a CQV Engineer supporting the commissioning and qualification of equipment within a Sterile Drug Product manufacturing facility. You will work with cross-functional teams to ensure systems are delivered safely, compliantly, and on schedule in line with GMP, EU, and FDA regulations.
Key Responsibilities
- Develop and execute CQV documentation and testing for assigned equipment.
- Support commissioning, qualification, and validation activities across the project lifecycle.
- Ensure testing complies with GMP, company procedures, and regulatory standards.
- Participate in Factory Acceptance Testing (FAT) and integrate results into qualification activities.
- Manage deviations and CQV risks, ensuring proper documentation and resolution.
- Collaborate with project teams to deliver high-quality CQV outcomes on time and within scope.
Requirements
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- 5+ years of pharmaceutical industry experience.
- Experience working with sterile drug product manufacturing equipment and automation.
- Strong documentation, communication, and problem-solving skills.
- Ability to work independently and within cross-functional project teams.
Ready to contribute to the delivery of critical pharmaceutical manufacturing projects?
Apply today and join a high-performing CQV team.
