23682 - Validation Engineer
CR/078752
Posted: 14/08/2025
- Competitive
- Ireland, County Louth, Dundalk
- Contract
Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Dundalk on an initial 6-Month contract.
The Validation Engineer is responsible for the planning and execution of the qualification activities associated with all facility, utilities, equipment and instruments and process, cleaning and shipping validations in compliance with all relevant cGMP regulations, company policies and procedures.
Role Functions;
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
The Validation Engineer is responsible for the planning and execution of the qualification activities associated with all facility, utilities, equipment and instruments and process, cleaning and shipping validations in compliance with all relevant cGMP regulations, company policies and procedures.
Role Functions;
- 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. Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.
- 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.
- 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.
- A bachelor’s degree qualification in an engineering or science discipline.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Jordan Robb
Recruitment Consultant
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