Validation Engineer

2 weeks ago

Dublin, Ireland Dps Group Global Full time

OverviewWe are seeking an experienced Validation Engineer to support the validation activities for a Syringe Filling Line within a sterile fill-finish facility.The successful candidate will ensure that all validation activities are executed in compliance with GMP standards and quality requirements.Key ResponsibilitiesGenerate, execute, review, and approve CQV test documentation including FAT, IVs, FTs, SATs, and PQs for the Syringe Filling Line.Review, pre-approve, and post-approve validation protocols.Contribute to site Validation Master Plans and Standard Operating Procedures (SOPs).Collate and report relevant validation data and metrics.Assist in exceptions, deviation resolution, and root cause analysis.Review validation planning documents detailing overall project strategy.Review and approve Qualification Summary Reports (QSRs).Generate Validation Summary Reports (VSRs).Support development of User Requirement Specifications (URSs) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).Education & Experience6+ years' experience in Engineering or Validation within the pharmaceutical/biotechnology industry.Technical qualification at third level (or equivalent) in Engineering or a related discipline.Extensive knowledge and proven experience in executing validation activities for pharmaceutical/biotech projects.Experience with sterile/biotech equipment in a pharmaceutical environment is highly desirable.Strong knowledge of GMP and safety requirements.Demonstrated strong communication and stakeholder management skills.Experience with Paperless Qualification Systems preferred.Solid understanding of risk-based approaches to commissioning, qualification, and validation in biotechnology.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering, Quality Assurance, and Project ManagementIndustriesEngineering Services and Pharmaceutical Manufacturing#J-18808-Ljbffr

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