Validation Engineer
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 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 of 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:
* Minimum Level 8 Degree
* 3-5 years equipment validation experience
* Previous medical device experience an advantage
Benefits:
* Competitive salary and holiday entitlements.
* Flexible hours and remote working options; role dependent.
* 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.
Job Types: Full-time, Permanent
Schedule:
* Monday to Friday
Work Location: In person
#J-18808-Ljbffr