Validation Engineer

Team Horizon is seeking a Validation Engineer for a leading pharmaceutical company based in Dublin. This is a permanent opportunity.

Why you should apply:

• You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin.


• You want to the opportunity to support a broad portfolio of project activities on site, including new equipment installations, process modifications and prsocess improvements relating to manufacturing, facility & packaging operation


• Join a company who offer competitive salaries, benefits and an inclusive environment

What you will be doing:

• Supporting on-site based projects for Oral Solids Dose Manufacturing, Facilities and Packaging operations.


• Development of the site validation strategy, validation plans, protocols and reports for all equipment and processes; incl. FATs/SATs, Product validation risk assessments, IOQs, PQs, etc.


• Performing activities in support of the validation programme such as risk assessments, and review and assessment of development data in line with recognised standards.


• Retrospective reviews and updates to existing validation systems or documents.


• Liaising with Manufacturing, Packaging, Facilities Engineering and end users on the completion of risk assessment for any product line extensions, process improvements or automation projects.


• Verifying that completed validation studies have been adequately recorded, documented and carried out, in accordance with the approved Validation Plan and Protocols.


• Ensuring that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation / Engineering Team.


• Providing assistance and ensuring the preparation of validation protocols, process design specifications and associated documentation for equipment and systems.


• Participating in project teams and assisting in determining project schedules and the relevance of appropriate levels of validation.


• Control and compliance of calibration schedules and associated instruments.


• Develop and maintain existing and future document control practices.

What you need to apply:

• Bachelor’s degree in engineering, Science or relevant Quality Discipline.


• 3-5 years' experience in the Pharmaceutical / Medical Device / Food Industry as a Validation Engineer.


• Background in Oral Solid dose Manufacturing & Packaging would be highly advantageous.


• Experience in cGMP, general manufacturing, facility & packaging systems would be highly advantageous.


• Ability and proven track record of working and managing multiple departmental teams for operational and capital projects.


• Excellent technical writing ability.


• Strong interpersonal and communication skills.


• Strong technical and problem-solving skills.