Validation Engineer- 6 month contract. A fantastic opportunity has arisen for a Validation Specialist. The successful candidate will take a lead on utilising the latest innovations in technology based in Co. Louth. Bring energy, knowledge, innovation to carry out the following: Support the site validation activities across a number of workstreams. Support 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 & risk assessment projects/meetings. Making 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: In order to excel in this role, you will more than likely have: 3-5 years 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/Chemistry etc. 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. Skills: validation equipment utilities facilities