Validation Engineer
RK26014
Contract 6 months
Louth



We’re 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.

• 3-5 years direct experience with a pharmaceutical or biotechnology company
• 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.