Job Description

Production Leader - Sterilisation

Ref No: AM17595

County Dublin, Republic of Ireland

Competitive salary

Production Leader - Sterilisation: South Dublin.

In this role you will be responsible for managing activities in the sterilisation area to:

(a) ensure that product is sterilised in accordance with the business requirements and the relevant validated parameters and
(b) ensure the maximum efficiency and flow of product through the area to final release.

A key part of the position is the requirement to work closely with the many internal and external stakeholders in the aterilisation process. The internal stakeholders include the site RPO (Radiological Protection Officer), Operators, Shift Managers, Technicians, as well as the relevant Engineering and QA Associates. The External stakeholders include the equipment suppliers and regulatory bodies.

Main responsibilities will include:
Ensure the sterilisation operation complies with required Environmental, Health & Safety requirements defined in the site safety procedures and best industry practice.
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.
Lead appropriate root cause investigation for any significant downtime or quality issues and ensure appropriate containment and preventative actions are in place.
Manage the Sterilisation Operator team across the shifts to ensure all activities are carried out safely and in line with the company’s expectations on performance and behaviours.
Manage the material flow through the sterilisation cell, including up and downstream, co-ordinating with respective stakeholders (operations, production coordinators, warehouse and supply chain).
Ensure all operations are carried out in accordance with the relevant cGMP's and safety standards.
Take a lead role in cobalt replenishment, dose mapping and validation activities, in collaboration with the site RPO, QA, Validation, Microbiology and Engineering teams.
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.
Manage third party contractor relationships required to support the operation of the department.
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.

Interested applicants should have a minimum of 5 years' experience in a supervisory or management role in manufacturing in a technical environment.
Thorough knowledge of production management principles, specifically strong scheduling and systems experience.
Ideally 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.
Proven process improvement experience, ideally with Lean and/or Six Sigma toolkit.


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