Senior CQV Engineer Job Description
Job Title: Senior CQV Engineer
Location: Carlow, Ireland
Contract Type: 12-month contract
About the Role:
PE Global is currently recruiting for a Senior CQV Engineer on behalf of a leading pharmaceutical company. This is an exciting opportunity to join the science, engineering, and manufacturing team to support the transition of a new facility from construction to a fully operational facility delivering life-saving products to patients.
As a Senior CQV Engineer, you will act as a technical SME and lead an experienced team in supporting the project from Operational Qualification (OQ) through to Equipment Performance Qualification, Validation, and Product PQ including filing with regulatory bodies.
Responsibilities:
- Manage workload and provide coaching for a team of Validation Engineers
- Align new facility introduction with Validation approach across Carlow site and review and approval of project VMP CQV approver for C&Q documents
- Act as Validation SME within a team of site representatives as system owner for PQ/Validation Site Acceptance Test Attendance
- Work with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/PQ executions
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
- Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification
- Working knowledge of ASTM E2500/Eudralex/FDA/ISPE guidelines
Desirable but not essential skills include experience with Vial & Syringe processing technologies, drug product filling, glass handling, tray handling, stoppering, capping, and CCI, Clean Utilities and HVAC system Qualification, New facility brown/green field facility introduction experience, and Small equipment qualification and validation.