Validation Engineer
RK24331
Contract 11 months
Louth



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Key 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.

• 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/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.
• EMPQ planning and execution experience
• Experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing of biologics.