We are seeking a highly skilled and experienced CSV Engineer to join our team in Waterford. This role will be based at our customer site, working within a sterile manufacturing environment.
The Role
The CSV Engineer will play a crucial part in:
* Leading and supporting validation activities for new and existing computerised equipment and control systems;
* Generating validation documentation (protocols/reports) and assisting with the execution of validation protocols;
* Participating in the change control process, providing expert advice on CSV matters;
* Contributing to the development and execution of DQ, IQ, OQ, and PQ protocols;
* Ensuring all projects meet cGMP, Health Safety, environmental, and regulatory standards.
The ideal candidate will have a degree in Science or Engineering, preferably in Chemistry, Microbiology, Pharmacy, Chemical, Mechanical, or Electrical fields, with 3–5 years' experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector.
Key Skills:
* Strong technical knowledge of pharmaceutical operations;
* Familiarity with GAMP, ISPE Baseline Guides, and quality/compliance regulations;
* Excellent communication and problem-solving skills.
Benefits:
* Professional growth opportunities;
* Total Rewards package;
* Equal Opportunity Employer status.
About Us:
We strive to create a diverse and inclusive workplace where all individuals are valued, respected, and supported.