Validation Engineer

Validation Engineer - Ireland, Dublin - 9 Month Contract

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting edge drugs.

What you'll do

• 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.

What you'll need

• Extensive 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.