Orion Group Life Sciences is recruiting a Validation Specialist for a multinational biopharma client based in County Louth, on a contract until the end of 2026.
Validation Engineer
The successful candidate will lead the use of innovative technology at the Drug Substance and Drug Product Facility, a new facility building to obtain qualification and continue product development. The site is the first facility in the network focused on manufacturing a live‑virus vaccine.
Responsibilities
Support site validation activities across a number of workstreams.
Support the site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
Support equipment qualification post‑Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent requalification/revalidation.
Support global regulatory submissions, internal audits and external inspections/audits as needed.
Facilitate problem solving and risk assessment projects/meetings.
Make problems visible and strive for continuous improvement.
Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc.).
Keep up to date with scientific and technical developments.
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
What skills you will need
3–5 years of direct experience with a pharmaceutical or biotechnology company, with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
Bachelor’s degree (or higher) in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
Experience in facility, utility and equipment qualifications, examples include CTUs, parts washers, autoclaves, clean utilities, cleanrooms/HVACs, etc.
Prior experience with upstream cell culture and/or downstream formulation/fill‑finish processes.
Prior experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing.
Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.
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