Validation Engineer

Validation Engineers

Galway

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 are excited to be expanding our team in Galway and are currently hiring Validation Engineers to join us on a range of dynamic projects.

If you're a dedicated professional eager to make an impact and work in a collaborative, fast-paced environment, we'd love to hear from you!

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.
• Carry out your duties to meet Quality, Safety and Environmental requirements at all times.

Requirements:

• Bachelor’s degree in Engineering, Science, or a related technical field (Mechanical, Electrical, or Biomedical Engineering is preferred).
• 3+ years of experience in validation within a regulated industry, such as medical devices, pharmaceuticals, or manufacturing.
• Familiarity with industry standards and guidelines
• Proven experience with equipment validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Previous medical device experience an advantage
• Strong problem-solving skills, with the ability to troubleshoot equipment issues and recommend effective solutions.
• Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders.
• Attention to detail and a methodical approach to ensure all equipment meets regulatory and company standards.
• Ability to work independently as well as in a team environment, with flexibility to adapt to changing project requirements.

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

• Competitive salary and holiday entitlements. 
• Flexible hours and remote working options; role dependant. 
• Pension Scheme.
• 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