As a CQV Engineer you will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment. The role supports both new and legacy equipment.
- Prepare, execute and report on CQV documentation.
- Complete field verifications during static and dynamic (functional) tests.
- Participate in startup activities of energized equipment where necessary.
- Interaction with vendors for project planning.
- Reviewing and approving project documentation, ensuring technical accuracy and adherence to cGMP.
- Perform system P&ID walkdown with construction prior to handover. Categorisation of punch list items & tracking to completion.
- Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
- Confirm the site installation is as per approved design specification and meet system IQ requirements.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support CQV.
- Participation in and execute design reviews (DQ), when required.
Requirements and Competencies
- Significant experience in the biotechnology and/or pharmaceutical industry, in a CQV role
- Proven experience in execution of CQV activities on a variety of Facility, Utility and Equipment Systems
- Experience with clean utilities and aseptic processing facilities would be an advantage
- Experience in Computer Systems Validation is desirable
- Experience in authoring, review and execution of CQV studies and reports is a must
- An Engineering or Science Degree is essential
- Experience of Commissioning Qualification in a project environment
- Experience in regulatory and industry standards for GMP and GDP
- Excellent technical writing skills including deviation reports and validation reports
- Self-Starter with time management and multi-tasking skills
- Available for travel as required
Why Choose This Role & SL Controls
- An excellent salary and benefits package including pension and health cover and other benefits such as:
- Educational assistance
- Income protection scheme
- Wellness and health initiatives
- The opportunity to work with clients who are global leaders in their field
- A supportive environment committed to employee development and wellness
- The opportunity to work with and help develop and improve upon industry leading technology solutions
- A collaborative and open culture where you are valued and have the opportunity to contribute to company initiatives and growth
About SL Controls
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 16 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Dublin and Florida. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.