Validation Engineer

Galway
Posted 2 months ago

About us

Atlantach Technical Services is an Engineering solutions company specialising in the project management, construction and commissioning market in Ireland and the USA. We are a trusted partner to leading blue chip companies across many sectors with project work spanning semiconductor, automotive, MedTech and Data Centre – just some of the focus areas we work in.

Join Our team

We have a dedicated team of highly skilled technicians and engineers with a wealth of experience and a proven track record of delivering results for our ever-growing client base.

Currently, we are looking for like-minded professionals to join our team and are hiring a Validation engineer to support a very high-profile client in Galway.

Duties and Responsibilities:

  • Contribute on the preparation and review of the Validation plans
  • Manage the preparation, review and issuing of Validation Protocols and Reports  
  • Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
  • Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams.
  • Establishing, implementing and directing validation and revalidation activities.
  • Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
  • Reviewing and managing Change Control Forms for Validation implications.
  • Reviewing and managing Non-Conformance’s for Validation Implications.
  • Updating existing quality documentation related to validation activities.
  • Identifying training requirements in support of validation.
  • Ensuring completion of validation protocols.
  • Carry out Internal Audits as required.
  • Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
  • Maintaining validation documentation system.
  • Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
  • Assisting in the preparation and hosting of associated regulatory and customer audits.

Authority:

  • You have authority to stop the job if you feel there is an unsafe work practice which could result in a risk of injury, have an environmental impact or risk to equipment and other personnel. 

Requirements:

  • Minimum Level 8 Degree
  • 3/5 years validation or software test background
  • Previous medical device experience an advantage

At Atlantach we offer a highly competitive benefits package, including:

  • Competitive salary and holiday entitlements
  • Flexible hours and remote working options; role dependant
  • Healthcare Insurance cover.
  • Further education financial assistance.
  • Access to a personal financial advisor.
  • Bike to work scheme.
  • Employee engagement and company-wide events.

Atlantach Technical Services is an Equal Opportunities Employer

Job Features

Job CategoryEngineering, Validation

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