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Senior Validation Engineer

Ref: 78319

  • 65,000-85,000
  • 21 Nov 2022
  • Offaly
  • Permanent

Senior Validation Engineer

About the Company

This is an exciting opportunity to join a leading Global Healthcare group with multiple sites across Ireland. They develop, manufacture and supply a range of Pharmaceuticals, Biologics, Medical Devices and Diagnostics Globally. They have a presence in Ireland with multiple manufacturing operations and commercial offices. 

About the Position

In this role you will contribute to the development of Validation Plans, Equipment Qualification Projects, Requalification Programs and Computer Systems Validation. The role is responsible for managing the timely development, execution and approval of all Laboratory validation programs and lifecycle documentation and to ensure completion of projects

Key Responsibilities

    • Work closely with validation contractors and quality control to generate and execute equipment qualification documents.
    • Coordinate and supervise validation testing performed by vendors and validation contractors.
    • Represent validation in multi-disciplinary teams focused on commissioning, validation, and computerized system validation.
    • Support the Periodic Review’s and revalidation program.
    • Ensure site alignment with corporate standards and cGxP guidelines.
    • Author and revise validation documents within the electronic documentation management system.

Experience/Requirements

  • BSc or equivalent experience in life science or engineering; knowledge in validation and quality compliance (cGMP/cGLP/ICH/FDA/USP/EU policies/guidelines).
  • At least 4 years Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience.
  • Validation experience with analytical lab equipment, support equipment, utility systems, computerized systems/automation, periodic reviews, cleaning, and process validation.
  • Validation Experience in analytical equipment qualification and data integrity processes

Remuneration Package

A strong salary and benefits package is on offer, fully negotiable depending on experience.
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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