Chief Validation Specialist

1 week ago

Limerick, Limerick, Ireland beBee Careers Full time

**Lead Validation Engineer Job Description**

Job Overview

This role involves leading the validation and qualification of equipment and processes, with a focus on creating quality validation process flow. The ideal candidate will have experience with process/equipment validation, CSV knowledge, and automation process validation.

Main Responsibilities:
  • Develop the overall validation and qualification plan/strategy in compliance with onsite governing procedures and aligned with the engineering Technology department.
  • Create quality validation process flow (e.g., V up to and including Regulatory submission).
  • Supporting validation from an automation perspective, actively guiding the site in transitioning from manual to automated validation methodologies.
  • Actively supporting the IQ | OQ | PQ, collaborating with a CSV-specific resource (assigned), therefore, understanding CSV is important.
Key Skills and Experience:
  • Process/Equipment Validation experience with CSV knowledge.
  • Background in Automation Process Validation, with an understanding (not expertise) of CSV.
  • Understanding of GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
  • Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
Benefits

The successful candidate will receive competitive salaries, pension, health care, life insurance, laptop, phone, access to extensive training resources, company discounts, on-site parking, and more.

Other Requirements

The candidate must be eligible to work in Ireland/EU.

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