Senior Validation Engineer 12 month contract On site Carlow
Job Description:
We are seeking an experienced Senior Validation Engineer to support the transition of a new biomanufacturing facility from project phase to a fully operational manufacturing facility.
* Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ including filing with regulatory bodies.
* Leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.
The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.
Key Responsibilities:
* Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on;
* Aligning new facility introduction with Validation approach across Carlow site and review and approval of project VMP CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures;
* Acting as Validation SME within a team of site representatives as system owner for PQ/ Validation Site Acceptance Test Attendance, hands-on support and C&Q Oversight for assigned process equipment.
The role requires strong leadership skills, with experience in managing teams and projects. The ideal candidate will have a strong understanding of validation principles and practices, as well as experience with regulatory requirements.
Requirements:
* Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
* Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
Experience with liaising with other departments Engineering, Automation, Technical, Operations, EHS and QA is also essential.