Sterilisation Validation Engineer
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Location:
Galway
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Contact email:
lfhiggins@sigmar.ie
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Sector:
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Contact phone:
+353 91 455 306
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Job type:
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Job ref:
LFHSVE1123
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Salary:
Negotiable per hour
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Published:
17 days ago
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Contact email:
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Consultant:
Job description
About Your New Employer
You will work as a Sterilisation Validation Engineer for a global medical device company who strive to design and manufacture ground-breaking healthcare technology solutions. You will join a team on their site in Galway on a 17-month contract. The successful candidate will have a Level 8 degree, previous experience working in the medical device industry and knowledge of GMP.
About Your New Job
As a Sterilisation Validation Engineer, you will…
- 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
What Skills You Need
- Level 8 degree in Science, Engineering or similar.
- 1-2 years related experience.
- Excellent knowledge of GMP is essential.
What’s on Offer
- 17-month contract
- Competitive hourly rate
What’s Next
- Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306
Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.