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Validation Engineer Contractor

1 month ago


Sligo, Sligo, Ireland TEAM HORIZON Remote Work Freelance Full time

Social network you want to login/join with:

Team Horizon is seeking a Validation Engineer for a 12-month contract for our client's manufacturing facility in Sligo.

Why you should apply:

  • Exciting opportunity to join a global pharmaceutical company and join a diverse and experienced team

What you will be doing:

  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Coordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
  • Generate and maintain the Validation Master Plans.
  • Generate and maintain Project Validation Plans.
  • Create validation plans, protocols, and final reports to cGMP standards.
  • Review and approve all protocols and final reports.
  • Manage the validation change control process.
  • Adhere to and support all EHS & E standards, procedures, and policies.

What you need to apply:

  • 3rd level qualification in a relevant engineering or scientific discipline.
  • A minimum of 5-10 years' experience in a cGMP regulated environment.
  • Good understanding of regulatory requirements.
  • Experience in Process validation (PPQ) in API or Drug product and managing validation events / Non-Conformances during PPQ.
  • FUE qualification essential (preferably API). Experience with working in fast-paced projects. Understanding of ASTM E risk-based qualification.
  • Good understanding of Critical Process Parameters/ Non-critical process parameters and their relationship with instrument calibration tolerances and selection of PPQ test criteria.
  • Ability to work directly with Engineering and other stakeholders to understand validation requirements.
  • Ability to react quickly to problems during validation.
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