Validation Engineer III Role Overview
This is a contract role for a renowned industry name in the Louth area. The successful candidate will be responsible for planning and executing qualification activities associated with all facility, utilities, equipment, and instruments.
Key Responsibilities:
* 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. Author, review, execution, and approval of testing protocols and reports.
* Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
* Will be flexible to take on additional tasks and responsibilities as requested. Will act as a role model for the Validation function and also the wider organization in adherence to the corporate core values.
Essential Requirements:
* A bachelor's degree qualification in an engineering or science discipline.
* 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.