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Sterilisation Process Owner

Location: Dublin
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Sterilisation Analyst

Sterilisation Process Owner
Our client, a Dublin based Medical Device organisation are currently recruiting for a Sterilisation Process Owner to join their team on a permanent basis. As Sterilisation Process Owner you will be responsible for coordinating activities in the Sterilisation Area to ensure that product is sterilised to the relevant validated parameters and ensure the maximum efficiency and flow of product through the area to final release.

• Work closely with internal and external stakeholders in the Sterilisation process. The internal stakeholders include Operators, Shift Leads, Technicians on the four shifts as well as the relevant Engineers and QA Associates. The External stakeholders include the equipment suppliers and regulatory bodies
• Ensure that product is sterilised in accordance with relevant validated parameters and the
business plan
• Manage product scheduling to ensure the optimal uptime of the cell
• Manage the Sterilisation Operator ensure all activities are carried out safely and in line with the Company’s expectations on performance and behaviors
• Ensure all operations are carried out in accordance with the relevant cGMPs and safety
• Take a lead role in cobalt replenishment, dose mapping and validation activities in collaboration with engineering expertise
• Improve cell efficiency so that the sterilisation capacity is adequate to service the increasing business needs
• Ensure the sterilisation cell, robots and all other equipment are maintained in accordance with operational requirements
• Ensure processes and procedures in the Sterilisation Department are maintained in compliance with relevant regulatory guidelines
• Provide reports on Sterilisation performance in accordance with business requirements
• As required, be involved in other Production Coordination or Project activities

• Third level qualification coupled in an Engineering or Science discipline or equivalent experience
• Minimum of 5 years in a Supervisory or Management role in manufacturing in a technical environment
• Thorough knowledge of production management principles, specifically strong scheduling and systems experience
• Solid experience in a regulated manufacturing environment
• Excellent documentation skills and attention to detail
• Excellent interpersonal and communication skills with proven track record in managing multiple stakeholders
• Strong PC skills with advanced skills in using MES and Excel a must
• Proven process improvement experience ideally with Lean and/or Six Sigma toolkit

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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