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Validation engineer

Dundalk
Life Science Recruitment Ltd
Validation engineer
Posted: 9 May
Offer description

Validation Engineer RK26014 Contract 6 months Louth Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Key Responsibilities: 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. Education and Experience: 3-5 years direct experience with a pharmaceutical or biotechnology company Bachelors 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. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

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