Validation Engineer Lead

2 days ago

Dundalk, Louth, Ireland beBeeValidation Full time €61,000 - €86,000

Experienced validation specialist sought for a 6-month contract role in the biopharmaceutical industry. Key responsibilities include planning and executing qualification activities, adhering to cGMP regulations and company policies.

Key Responsibilities:

  • Execute qualification and validation activities using a life cycle approach following validation plans and complying with cGMP and company procedures from design through ongoing operations.
  • Author, review, execute, and approve testing protocols and reports. Deliver projects, participate on project teams, respond to vendor inquiries, troubleshoot process systems, and ensure regulatory compliance.
  • Perform duties in accordance with GMP requirements, SOPs, and controlled documents.
  • Be flexible and take on additional tasks and responsibilities as requested.

Essential Requirements:

  • A bachelor's degree in engineering or science.
  • 3-5 years of experience working in pharmaceutical or similar GMP environments within a validation, MSAT, or engineering function.
  • Experience in commissioning and qualification/validation of facilities, utilities, equipment, and instruments (e.g., bioreactors, process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
  • Maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).
  • Troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
  • Equipment vendor package ownership and system design coordination.

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