Validation Engineer

Sci Pro Newry, Northern Ireland, United Kingdom

Sci Pro 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 Track Wise or similar quality systems (preferred).

Why You Should Join Our Client:

• Seniority level Associate

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance
• Industries Pharmaceutical Manufacturing

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