Overview:
We are currently supporting a leading pharmaceutical client in their search for an experienced CQV / Validation Engineer to support ongoing project activities. This role will report directly to either the Senior Project Engineer or Senior Process Engineer, and will play a critical part in the commissioning, qualification, and validation (CQV) of both new and existing process equipment.
Key Responsibilities:
- Lead and execute equipment validation activities including Installation Qualification (IQ) and Operational Qualification (OQ).
- Develop and author full validation documentation, including but not limited to:
- FAT / SAT protocols and reports
- Impact Risk Assessments (IRA)
- Traceability Matrices
- CSV-compliant documentation
- Support revalidation efforts for second-hand or modified process equipment.
- Collaborate closely with engineering and operations teams to ensure all systems meet regulatory and GMP requirements.
- Coordinate and support execution of testing activities in alignment with project timelines and quality standards.
Required Skills and Experience:
- Proven track record in CQV / Validation within a regulated pharmaceutical environment.
- Strong documentation skills with the ability to write comprehensive and compliant validation protocols and reports independently.
- In-depth knowledge of powder and liquid pharmaceutical processes, including:
- Granulation
- Tablet Compression
- Fluid Bed Drying
- Automated Filling Lines
- Packaging / Blister Lines
- Familiarity with regulatory expectations and industry standards related to CSV and equipment validation.
- Ability to hit the ground running with minimal supervision.
Preferred Experience:
- Previous work on projects involving both new equipment commissioning and revalidation of second-hand machinery.
- Experience working cross-functionally within multi-disciplinary engineering or manufacturing teams.
- Flexible and solutions-driven approach with a hands-on attitude.
Why Apply?
- Opportunity to work on high-impact pharmaceutical capital projects.
- Collaborate with industry-leading professionals in a technically challenging environment.
- Competitive rates and the potential for long-term engagement.
Job Types: Full-time, Permanent
Benefits:
- Company pension
- Employee assistance program
- On-site parking
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work authorisation:
- Ireland (required)
Work Location: In person