Equipment Validation Specialist

6 days ago

Cork, Cork, Ireland beBeeValidation Full time €80,000 - €100,000

Gain unrivalled experience working with international brands as a Validation Specialist at PM Group. Partnering with us and our clients offers you the opportunity to work on diverse projects and develop your skills.

About the Role

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.
Requirements
  • Bachelor's degree 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.
About Us

The Outsourced Technical Services Department partners with global leaders across various industries to find the best talent for their business needs. Our clients offer opportunities to gain experience working with international brands.

A Validation Engineer plays a critical role in ensuring that equipment meets regulatory requirements by developing and implementing comprehensive validation plans.

To succeed in this role, you will need to have strong technical knowledge of equipment design, installation, operation, and maintenance, as well as excellent communication and project management skills.

This position requires a collaborative mindset, with the ability to work effectively with cross-functional teams, including Manufacturing, Engineering, Process Support, Supply Chain, and Quality.

You will also need to stay up-to-date with industry developments and regulatory changes, ensuring that our equipment validation programs remain compliant and effective.

This is an excellent opportunity for a skilled and motivated individual to join our team and contribute to the success of our clients.

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