Overview
Ref. 1351
Validation Engineer (EMPQ)
A fantastic opportunity has arisen with our client, a leading multinational pharmaceutical company, for a Validation Engineer. The successful candidate will take a lead in utilising the latest innovations in technology. The role is based at Dundalk, Co. Louth.
The role involves driving the development of the site EMPQ strategy and implementing and maintaining environmental monitoring protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
Responsibilities
- Support the site validation activities across several workstreams.
- Create and maintain the site Validation Master Plan.
- Drive development of site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
- Perform/involved in risk-based EM assessments to determine the environmental monitoring requirements.
- Coordinate EMPQ validation studies, ensuring proper execution, data collection, and documentation.
- Draft, review and approve validation documentation, reports, and deviation investigations.
- Collaborate with production and quality control teams to establish EM procedures, sampling routines and requirements.
- Periodic classification of areas/EM programs to ensure their ongoing effectiveness.
- Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.
- Support global regulatory submissions, internal audits and external inspections/audits as needed.
- Facilitate problem solving & risk assessment projects and 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).
- Maintain a consistent commitment to quality and safety compliance, with an unwavering focus on the customer.
Requirements
- 3-5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- A Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
- Proven experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
- Proven experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.
- Experience with Technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing of biologics.
- Minimal work direction needed.
- Strong technical writing and oral communication skills.
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