Validation Engineer

Ref. 1384

Validation Engineer

A great opportunity has become available with our client, a leading multinational pharmaceutical company, for a Validation Engineer based in Dundalk, Co. Louth, within a Drug Substance and Drug Product facility. The successful candidate will play a key role in leveraging the latest technological innovations.

This is a 6-month contract opportunity.

Responsibilities:

·       Provide 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.

·       Assist with 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.

·       Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).

·       Promote visibility of issued and strive for continuous improvement.

·       Keep up to date with scientific and technical developments.

·       Maintain a strong focus on quality and safety compliance and unflinching focus on the customer.

Requirements:

In order to excel in this role, the successful candidate will more than likely have:

·       3-5 years of direct experience within 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.

·       Demonstrated experience in Facility, Utility and Equipment qualifications, examples include CTUs, Parts Washers, Autoclaves, Clean Utilities, Cleanrooms/HVAC Systems, etc.

·       Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.

·       Hands-on experience with upstream cell culture and/or downstream formulation/fill finish processes.

·       Experience in technology transfer, regulatory submissions, and commercial manufacturing of drug substance and/or drug product.