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:
* Bachelor’s degree in a relevant discipline
* 1-2 years of experience required
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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