Validation Engineer (Cleaning Validation)

Ref. 1353

Validation Engineer (Cleaning Validation)

A fantastic opportunity has arisen 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.

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• Support the site validation activities across several workstreams.
  
• Create 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.
  
• Assist global regulatory submissions, internal audits and external inspections/audits as needed.
  
• Support problem-solving and risk assessment projects and meetings, highlighting issues and driving continuous improvement.
  
• Lead and support various organizational initiatives as needed (e.g. safety, financial forecasting, work standardization, etc).
  
• Guarantee continuous focus on quality and safety compliance and unflinching focus on the customer.
  

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• 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 or similar discipline.
  
• Proven experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
  
• 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.
  
• Experience with upstream cell culture and/or downstream formulation/fill finish processes. xcfaprz
  
• Strong technical writing and oral communication skills.