CQV Lead Engineer - North of Ireland
This is a superb opportunity to join a global pharmaceutical organization in their new multifunctional facility. As one of the top 10 best companies to work for in Ireland, we are known for our exceptional workplace culture and opportunities for growth.
Essential Duties and Responsibilities
1. We are seeking a CQV Lead Engineer to oversee the Validation & PQ aspects of projects within a team of Validation professionals.
2. The successful candidate will be responsible for ensuring right first-time C&Q and Validation effort across equipment in assigned areas.
3. As a Subject Matter Expert (SME), you will provide technical and validation oversight to process, design and project delivery teams.
4. You will implement site and project Validation Master Plans, coordinating engineering sub-teams during Cycle Development & Validation activities.
5. Your responsibilities will include authoring and reviewing standard operating procedures and technical reports, as well as providing technical review and approval of Commissioning protocols.
6. Additional duties will include supporting regulatory submissions and owning Change Management processes for Equipment introduction.
7. The ideal candidate will have experience in LeanSixSigma and Change Management tools, applying them to achieve results using industry-standard tools and processes.
Desirable Experience
1. We are looking for candidates with extensive C&Q/ QA/ QC/ Validation experience in a highly regulated industry.
2. Experience in process equipment C&Q/ QA/ Validation on Greenfield / Brownfield, Large Scale Project or new facility introduction is highly desirable.
3. Presenting QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach is a key requirement.
4. SME on Equipment Qualification on Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection would be advantageous.
5. A working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines is essential.
6. Liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA is a key aspect of this role.