Atlantach Technical Services is an engineering solutions company specialising in Project Management, Operations & Maintenance and Commissioning.
Join Our Team
At Atlantach Technical Services, Ambition drives us to continuously improve and grow. Teamwork strengthens our collaboration and respect. Success is achieved together. Join us in shaping your career, where ambition is realised, teamwork is at our core and success is celebrated.
We are currently hiring a Senior Validation Engineer to support our high profile medical device 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.
* 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
* 5+ years of experience in validation within a regulated industry, such as medical devices, pharmaceuticals, or manufacturing.
* Previous experience of Utilities Validation
* 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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Other
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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