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Lead, Validation

https://www.baxter.com/ Logo

Baxter

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Location:
Ireland , Dublin

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The role of the Validation Lead is to conduct, coordinate and manage project related validation activity in order that validation documentation is prepared to the necessary standards and executed in line with the overall Project Validation Master Plan for Ireland Compounding in our South Dublin Sites.

Job Responsibility:

  • Lead validation activities on specific projects including defining the validation requirements to ensure compliance and industrial guidance
  • Ability to translate local, corporate and regulatory requirements into validation requirements
  • Liaise with project team members
  • Change Control Management
  • Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes
  • Run validation project execution IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved
  • Deviation / Non- Conformance management (including RA, RCA & CA/PA)
  • Proactively coordinate validation activities and act as a central point of contact for the project team for validation to ensure the projects are delivered on schedule
  • Author and report validation documentation to meet regulatory and Baxter standards
  • Resolve both GMP and business issues and deviations
  • Plan and prioritise their work load to ensure that agreed deadlines are met
  • Provide periodic updates to the Validation Supervisor, Process QA Manager and Quality Assurance Leaders
  • Ensuring validation documents are in a constant state of "audit readiness"

Requirements:

  • Strong validation and install experience in relation to Facilities and Utilities in a Pharmaceutical, Medical Device or similar environment
  • Minimum: degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience
  • Experience in Facilities and Utilities project validation to include HVAC, Cleanroom, Compressed Air etc.
  • Experience in 6-Sigma and Lean Manufacturing
What we offer:
  • Pension
  • Annual Bonus
  • Health Insurance
  • Life Assurance
  • Work life Balance
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 13, 2026

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