Validation Engineer

5 days ago

Cork, Cork, Ireland PM Group Full time

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Overview

The Outsourced Technical Services (OTS) Department at PM Group partners with global leaders across various industries to find the best talent for their business needs. Partnering with PM Group and our clients offers you the opportunity to gain unrivalled experience working with international brands.

We are seeking an experienced Validation Engineer to work onsite in Cork. The role involves equipment validation related to technology transfer of existing processes from another site.

Responsibilities
  • Perform Qualification and Validation of Manufacturing, QC, and Supply Chain equipment, including FAT, SAT, IQ, OQ, PQ, cleaning, temperature mapping, and sterilization.
  • Maintain validation programs to ensure GMP compliance of manufacturing equipment, facilities, utilities, computer systems, and processes.
  • Conduct equipment design qualification and risk assessments to verify compliance with specifications and requirements.
  • Coordinate validation activities with Manufacturing and Quality Control teams, analyzing results against acceptance criteria.
  • Collaborate with Manufacturing, Engineering, Process Support, Supply Chain, and Quality to meet regulation and quality standards.
  • Prepare and review validation documentation, including CQV protocols, calibration specifications, and out-of-tolerance records.
  • Manage quality system elements such as Change Controls, Deviations, and Investigations related to validation activities.
Qualifications
  • B.S. in Engineering with 3-7 years of relevant experience or equivalent.
  • Experience with cGMPs and Good Engineering Practices.
  • Proven ability to manage multiple projects and work in cross-functional teams.
  • Knowledge of automation validation is preferred.
  • Experience with Quality control equipment qualification is a plus.
Additional Information

Position is full-time, located in Cork, Ireland, and falls under the Quality Assurance function within Construction and Design Services industry.

Note: This job posting is active; no indication of expiration was found.

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