Job Opportunity: We are recruiting for an exciting role within a Biopharmaceutical organization based in Dundalk. This is a fantastic opportunity for someone looking to join a leading multinational company who are one of the best at what they do.
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* Key Responsibilities:
o Execute qualification and validation activities for life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state.
o Author, review, execution and approval of testing protocols and reports.
o Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.
o Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Requirements and Qualifications:
* A minimum of 3 - 5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function.
* Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
* Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).
* Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
* Experience of equipment vendor package ownership and system design coordination.
Benefits:
This role offers the opportunity to work with a leading multinational company who are one of the best at what they do.
How to Apply:
If interested in this posting please contact Seán McCarthy on +353 (0)87 798 8480 for further information.