SciPro Newry, Northern Ireland, United Kingdom
Validation Engineer
SciPro Newry, Northern Ireland, United Kingdom
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We are currently seeking a Validation Engineer to join our Newry team. This role is crucial in ensuring our products, equipment, computer systems, and cleaning processes remain qualified and compliant with industry standards.
The Role:
- Conducting data analysis and reviewing commercial products to maintain validated processes through Continuous Process Verification (CPV), supporting Quality Annual Product Reviews (APRs).
- Writing Process Validation strategies, protocols, reports, validation plans, SIAs, DIAs, and executing computer system validation activities.
- Performing Cleaning Validation assessments and compiling relevant protocols and summary reports.
- Supporting equipment validation, including routine temperature mappings across fridges, freezers, freeze tunnels, stability facilities, incubators, and warehouse storage.
- Reviewing User Requirement Specifications (URS) and overseeing validation plans, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Equipment Qualification (IOPQ).
- Conducting validation history reviews, ensuring alignment with the latest regulatory requirements and identifying re-qualification needs.
- Leading deviation investigations using Root Cause Analysis and implementing appropriate Corrective and Preventive Actions (CAPA).
- Upholding employer and employee Environmental Health & Safety (EH&S) obligations, including participation in office safety inspections.
The Candidate:
- Experience in Quality Assurance, preferably within the pharmaceutical or medical devices industry.
- A science-based degree or relevant industrial experience.
- Strong numeracy and literacy skills.
- Confident user of Microsoft Excel & Minitab.
- Experience with TrackWise or similar quality systems (preferred).
Why You Should Join Our Client:
Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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