Validation Engineer
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Responsibilities
Requalification Execution: Lead the execution of the Requalification (RQ) schedule, focusing on technical protocols for Autoclaves, SIP, and TCU systems.
Documentation & Reporting: Draft and finalize technical summary reports, protocols, and standard operating procedures to ensure regulatory compliance.
Discrepancy Resolution: Manage the full lifecycle of technical discrepancies, from initial drafting and technical investigation to final closure and resolution.
System Proficiency: Maintain high-level expertise in industry software including Veeva Vault, Ellab (ValSuite), Darwin, GMARS, and Meridian.
Cross-Functional Collaboration: Coordinate with Automation, Maintenance, Quality, and Process Engineering teams to ensure projects are completed on schedule.
Continuous Improvement: Identify and implement enhancements to the RQ program to improve quality, streamline workflows, and increase operational efficiency.
Compliance & Safety: Ensure strict adherence to site safety rules and maintain up-to-date training via Success Factors to meet all quality standards.
Experience / Qualifications
Autonomy in Requalification: Independently manage and execute the full RQ schedule for Autoclaves, SIP, and TCU systems without direct supervision.
Technical Documentation Ownership: Author and approve audit‑ready IQ/OQ/PQ protocols and summary reports that meet strict GxP and site standards.
Expert Discrepancy Resolution: Lead investigations into technical failures, performing Root Cause Analysis (RCA) and drafting effective closure plans.
System Mastery: Serve as a "power user" in site software (Veeva, Ellab, Darwin, GMARS) to ensure data integrity and process efficiency.
Project Liaison: Proactively coordinate with Automation and Quality teams to resolve bottlenecks and keep validation timelines on track.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Pharmaceutical Manufacturing
Next Steps
To discover more about this opportunity please apply online or contact Darragh on +353 879345234 for a confidential discussion.
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