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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Validation Lead


Reference:AMC3472 Location: Dublin South
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Manager

Validation Lead - Fill Finish
12 month contract
South Dublin
AMC3472


I am on the lookout for a Validation Lead for a large scale, Fill Finish project with one of my Biopharmaceutical clients. In this role you will lead a team of Validation engineers to ensure that a large fill finish project is a completed safely, on time and in compliance with GMP and Quality Requirements.

If you have a relevant degree along with 7+ years in Validation in the pharmaceutical and biopharmaceutical industry this could be the role for you!

Key responsibilities:

  • Oversee and coordinate all validation activities.
  • Approve validation planning documents outlining the overall project strategy.
  • Develop and approve the master list of validation test documents and activities.
  • Review and approve all Commissioning & Qualification (C&Q) summary reports and validation summary reports.
  • Ensure the validation schedule is established and maintained.
  • Verify that all validation engineers conducting validation activities have the necessary training.
  • Manage the pre-approval and post-approval of validation test documents.
  • Organize and lead validation coordination meetings.
  • Track and report on validation status, including risks and issues.
  • Assist in developing User Requirement Specifications (URS) and conducting Quality Risk Assessments for equipment and automated systems (QRAES).

Key requirements:
  • Bachelor of Science or equivalent degree
  • 7+ years experience gained in Validation, Engineering, Microbiology or Quality
  • Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
  • Sterile/Biotech equipment validation experience
  • Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
  • In-depth understanding and application of validation principles, concepts, practices, and standards.
  • In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
  • Working knowledge of sterilization/decontamination systems and industry practices.
  • Experience with AVS (Airflow Visualization) Studies.
  • Experience of aseptic processing


If this sounds like you please apply today and I will be in touch with more info.