Sterilisation Validation Engineer

Sterilisation Validation Engineer I Responsibilities: Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etcSupport sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sitesParticipate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementationSupport cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standardsCollaborates with engineering and manufacturing functions to ensure quality standards are in placeDevises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.Performs calculations, data integrity checks, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirementsAdhere to all relevant site wide procedures and practices for Safety & GMPRequirements: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2-5 years of relevant experience.
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