Sterilisation Validation Engineer

Desired Skills: validation,sterility assurance,quality

JOB DESCRIPTION

Sterilisation Validation Engineer I

Duration: 12 Months

Location: Galway, Hybrid Role

Responsibilities:

Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc
Support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation
Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises 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 requirements
Adhere to all relevant site wide procedures and practices for Safety & GMP

Education and Experience: