Validation Engineer

1 week ago

Dublin, Dublin City, Ireland Independent Solutions Full time

Job Title: Senior Validation Engineer or/ Validation Engineer

Employment Type: Fixed Term Contract (11 months, PAYE)

Start Date: ASAP

Location: On-site role in Carlow, Ireland

Remote Working: Not available (Hybrid)

Pay rate: Euros 28 -45/hr

Role Overview:

We are seeking a highly skilled Senior Validation Engineer (or Validation Engineer) for a regulated cGMP manufacturing environment. The successful candidate will play a key role in cleaning validation activities, including recovery and cleanability studies.

Key Responsibilities:

  • Develop and execute validation protocols (CD, PQ, and cycle development studies).
  • Manage and implement change controls, addressing technical challenges during execution.
  • Collaborate cross-functionally with Production, Maintenance, and Quality teams.
  • Participate in quality investigations and root cause analyses of system deviations.
  • Support and drive continuous improvement initiatives through Lean/Six Sigma tools.
  • Act as a validation representative in projects and global technical forums.
  • Please ensure compliance with current Good Manufacturing Practice (cGMP), internal Standard Operating Procedures (SOPs), and applicable regulatory standards.
  • Contribute to regulatory audits and submission preparations.

Essential Experience & Skills:

  • Strong background in cleaning validation, including CIP/COP, TOC, ICP, and swab methods.
  • Hands-on experience with equipment and process validation, especially in a GMP manufacturing setting.
  • Familiarity with Deviation/Exception Management and Change Control systems.
  • Knowledge of DeltaV automation, PI system, and other monitoring/data systems.
  • Strong analytical, reporting, and technical writing skills.
  • Solid understanding of regulatory compliance and industry codes/standards.
  • Excellent communication, team collaboration, and presentation skills.

Desirable Knowledge:

  • Filter Validation, CCI Qualification, Equipment Validation Lifecycle.
  • Vial/Syringe Technologies, Isolator VHP, HVAC Qualification.
  • Project Management Certification.
  • Exposure to SIP/autoclave, dry heat sterilization, and shipping qualification.

Qualifications:

  • Degree in Applied Pharmaceutical, Biological, Chemical Sciences, or a related Engineering discipline.
  • Proven track record in executing validation work within a regulated manufacturing environment.
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