EHS | Sustainability | R&D | Design Assurance | MedTech Engineering | Pharmaceutical
Duration: 15 Months Contract
Location: Galway
Non Negotiables:
1-2 years experience in a similar role
Level 8 University degree in a related discipline
Medical Device industry experience required
Based in Galway so must be willing to be onsite as required
Sponsorship not possible, MUST HAVE a valid work permit for Ireland that allows you to work uninterrupted for 15 months.
Responsibilities may include the following and other duties may be assigned
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
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree and 1-2 years of experience.
Seniority level
Associate
Employment type
Temporary
Job function
Quality Assurance and Engineering
Industries
Medical Equipment Manufacturing
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