Job Description
The Validation Specialist will provide leadership in employing innovative technology to support validation activities at the Drug Substance and Drug Product Facility in Co. Louth. The role focuses on ensuring compliance with regulatory guidelines while supporting the introduction of a live virus vaccine manufacturing line.
Location: Dundalk, Louth, Ireland
Responsibilities
Support the site validation activities across a number of workstreams.
Develop and maintain the site Validation Master Plan.
Drive development of site cleaning strategy and implement/maintain cleaning and sanitisation protocols and procedures for pharmaceutical equipment, ensuring compliance with regulatory guidelines.
Perform risk assessments to determine the criticality of cleaning processes and set acceptance criteria.
Oversee cleaning validation studies, ensuring proper execution, data collection, and documentation.
Collaborate with production and maintenance teams to establish cleaning procedures and cleaning validation requirements.
Draft, review and approve cleaning validation documentation, reports, and deviation investigations.
Conduct periodic reviews of cleaning validation 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/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.
Skills Required
3-5 years direct experience with a pharmaceutical or biotechnological 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.
Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
Experience with upstream cell culture and/or downstream formulation/fill finish processes.
Experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing of biologics.
Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.
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