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 Senior 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 equipment validation experience
- 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 Category | Engineering, Validation |