Validation Specialist

Orion Group Life Sciences are currently recruiting a Validation Specialist on behalf of our Multinational Biopharma Client based in Co. Louth on an initial contract to the end of 2026.

Validation Engineer:
A fantastic opportunity has arisen for a Validation Specialist. The successful candidate will take a lead on utilising the latest innovations in technology. The role is based at the Drug Substance and Drug Product Facility in Co. Louth which is a new facility build working to obtain qualification and continued product development. The site is the first facility in the network focused on manufacturing a live virus vaccine.
 
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/BiologicalEngineering/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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