Lead Validation Engineer for Equipment and Process Validation

1 week ago


Limerick, Limerick, Ireland beBee Careers Full time

We are seeking a skilled Lead Validation Engineer to join our growing team. The ideal candidate will have a strong background in process/equipment validation and computer system validation (CSV).

Key Responsibilities

  • Develop and implement the master validation plan, validation strategy, and create the validation output document.
  • Support validation from an automation perspective, guiding the site in transitioning from manual to automated validation methodologies.
  • Have full technical oversight and lead the overall validation & qualification of equipment and processes.
  • Collaborate with QA Team to ensure agreement to the overall strategy and resolve any issues that arise.

Required Skills and Qualifications

  • Process/Equipment Validation experience with CSV knowledge.
  • Background in automation process validation, with an understanding of CSV.
  • Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
  • Understanding of FDA 21 CFR Part 11, ISO Standards, and Validation Lifecycle Management.

Benefits

  • This is a permanent role based in Limerick City.
  • The company offers competitive salaries, including pension, healthcare, life insurance, laptop, phone, access to extensive training resources, company discounts, on-site parking, and more.


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