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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Validation Engineer


Reference:RK24331 Location: Republic of Ireland
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

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.


Education and Experience:
  • 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.



If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.