Validation Engineer
3 weeks ago
Validation Engineer - Galway. This is a contract posting of 24 months' duration. We are seeking a skilled Validation Engineer for design, documentation and release of Test Method Validation Operating Procedures. This role involves training and supporting of these procedures through adoption and into maturity, ensuring compliance with ISO, PMDA and FDA requirements. The engineer will design, schedule and execute test method validations from incoming inspection, in-process and finished product inspection. Additionally, the engineer will provide early stage consultation to other departments on test method requirements at project proposal stages and support other departments in documenting, performing and improving test methods and inspection procedures. The role requires using relevant statistical bases to demonstrate that the test methods are accurate, precise and reliable, and participates in the development of new test methods where required to meet these criteria. The engineer will also support other validation activities with subject matter expertise and guidance, reviewing external testing partners methodologies, protocols and reports for compliance with relevant regulatory requirements. Role & Responsibilities: Working as part of a cross-functional project team, the engineer will be responsible for the site test method validation related activities; Estimation of validation timelines & resource requirements Generate and approve standard operating procedures for test method validation Ensuring compliance of test method validation process with ISO, PMDA, FDA regulatory requirements Generate and approve test methods Master Validation Plan & Report Generate and approve test method validation protocols and reports Actively involved in the development of risk assessments (FMEA) Co-ordinate and execute validation activities Provision of project progress updates to the Site Validation Lead Escalate validation related issues and risks in a timely manner Perform statistical analysis of validation results for comparison to acceptance criteria Train and mentor team members on validation processes and procedures Qualifications and Job Requirements: A minimum of 5-8 years working in a relevant medical device or pharma manufacturing environment Relevant third level qualification in science or engineering Knowledge of medical device manufacturing from a validation, regulatory, or testing perspective Practical experience and good working knowledge of test methods Knowledge of the regulatory framework around medical device validation requirements Proven ability to work as part of a multi-disciplinary team in a dynamic environment Proven track record of committing to and meeting deadlines Effective communicator with all levels of the organisation and interaction with customers Excellent analytical, numerical, problem solving skills and attention to detail Skills: validation engineer validation scientist manufacturing
-
Validation Engineer
3 weeks ago
Galway, Galway, Ireland ICDS RECRUITMENT CONSULTANTS LTD Full timeValidation Engineer - Galway.This is a contract posting of 24 months' duration.We are seeking a skilled Validation Engineer for design, documentation and release of Test Method Validation Operating Procedures. This role involves training and supporting of these procedures through adoption and into maturity, ensuring compliance with ISO, PMDA and FDA...
-
Validation Engineer
2 weeks ago
Galway, Galway, Ireland recruitireland - jobboard Full timeThis is a contract posting of 24 months' duration.We are seeking a skilled Validation Engineer for design, documentation and release of Test Method Validation Operating Procedures. This role involves training and supporting of these procedures through adoption and into maturity, ensuring compliance with ISO, PMDA and FDA requirements. The engineer will...
-
Validation Engineer
3 weeks ago
Galway, Galway, Ireland Goodman Medical Ireland Ltd Full timeGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Goodman Medical Ireland LtdHR Manager at Goodman Medical Ireland LtdGeneral DescriptionWe are seeking a skilled Validation Engineer to design, document, and release Test Method Validation Operating Procedures. This role involves training and supporting these...
-
Validation Engineer
4 weeks ago
Galway, Galway, Ireland Goodman Medical Ireland Ltd Full timeGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Goodman Medical Ireland LtdHR Manager at Goodman Medical Ireland LtdGeneral DescriptionWe are seeking a skilled Validation Engineer to design, document, and release Test Method Validation Operating Procedures. This role involves training and supporting these...
-
Validation Engineer
2 weeks ago
Galway, Galway, Ireland TN Ireland Full timeOur client based in Westport is looking to hire a Validation Engineer for an exciting new project.There are permanent and fixed-term opportunities available.Responsibilities:Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner.Ensure all validation...
-
Validation Engineer
2 weeks ago
Galway, Galway, Ireland Sigmar Recruitment Full timeAbout Your New EmployerThis employer is Galway based well established medical devices company designing, developing and manufacturing balloon and stent catheters and sells primarily to the Japanese market. They have subsidiaries in Japan, Ireland and USA.About Your New Job as a Validation EngineerDesign, scheduling and execute test method validations from...
-
Validation Engineer
2 weeks ago
Galway, Galway, Ireland GxP Recruitment Full timeWe are looking for a dynamic QA Validation Engineer for a long term contract with a leading medical device client in Galway.Note: No sponsorship will be provided for this contract role. A validation Stamp 1G or Stamp 4 is required at minimum. Previous Medical Device experience required.Prepare all lifecycle documentation required such as Functional...
-
Validation Engineer
1 day ago
Galway, Galway, Ireland TN Ireland Full timeAn important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing validation protocols and reports and also the coordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments.KEY...
-
Validation Engineer
2 weeks ago
Galway, Galway, Ireland Cpl Full timeOverview: An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant...
-
Contract Validation Engineer
4 weeks ago
Galway, Galway, Ireland Quanta Consultancy Services Ltd Full timeContract Validation Engineer - Ireland - 9 Months ContractAre you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland? Our esteemed client is looking for a Contract Validation Engineer to join their team in their existing manufacturing facility in Ireland.The facility is responsible for tablet manufacturing (OSD) and...
-
Contract Validation Engineer
2 weeks ago
Galway, Galway, Ireland Quanta Consultancy Services Ltd Full timeContract Validation Engineer - Ireland - 9 Months ContractAre you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland? Our esteemed client is looking for a Contract Validation Engineer to join their team in their existing manufacturing facility in Ireland.The facility is responsible for tablet manufacturing (OSD) and...
-
Sr. Validation Engineer
2 weeks ago
Galway, Galway, Ireland EPM Scientific - Phaidon International Full timeSenior Validations EngineerThe requirements of this role within the wider project are to cover the validation activities with respect to the testing and manufacture of the client's device.Role/ Responsibilities:- Develop, and/or approve, validation documentation, including protocol, records, and reports.- Performing and overseeing process and test method...
-
Validation Engineer Ireland
2 weeks ago
Galway, Galway, Ireland Quanta Consultancy Services Ltd Full timeContract Validation Engineer Opportunity in Ireland - Join our esteemed client in their existing manufacturing facility and contribute to the maintenance of manufacturing operations. This role involves working alongside a global pharmaceutical organisation to ensure compliance with regulatory requirements and industry standards.The ideal candidate will have...
-
Test & Validation Engineer
4 weeks ago
Galway, Galway, Ireland Atlantach Technical Services Full timeGalway, IrelandPosted 3 weeks agoAbout UsAtlantach Technical Services is an engineering solutions company specialising in Project Management, Operations & Maintenance and Commissioning.Industries we work inSemi-Conductor | Pharma | Med Device | Datacentre | AutomotiveJoin Our teamAt Atlantach Technical Services, Ambition drives us to continuously improve and...
-
Test & Validation Engineer
2 weeks ago
Galway, Galway, Ireland Atlantach Technical Services Full timeGalway, IrelandPosted 3 weeks agoAbout UsAtlantach Technical Services is an engineering solutions company specialising in Project Management, Operations & Maintenance and Commissioning.Industries we work inSemi-Conductor | Pharma | Med Device | Datacentre | AutomotiveJoin Our teamAt Atlantach Technical Services, Ambition drives us to continuously improve and...
-
Senior Validation Engineer
4 weeks ago
Galway, Galway, Ireland Atlantach Technical Services Full timeGalway, IrelandPosted 1 month agoAbout UsAtlantach Technical Services is an engineering solutions company specialising in Project Management, Operations & Maintenance and Commissioning.Industries we work inSemi-Conductor | Pharma | Med Device | Datacentre | AutomotiveJoin Our teamAt Atlantach Technical Services, Ambition drives us to continuously improve and...
-
EMC Validation Engineer
2 weeks ago
Galway, Galway, Ireland TN Ireland Full timeTeam Horizon is seeking an EMC Validation Engineer for a leading manufacturing company based in North Galway. The role is responsible for all EMC Validation activities from RFQ phase to final customer acceptance of a defined project, running the activities for one project according to company rules and international standards. Optionally, the role of ET...
-
Senior Hardware Validation Engineer
4 days ago
Galway, Galway, Ireland SPEEDECK Full timeAbout the RoleWe are seeking a highly skilled Senior Hardware Validation Engineer to join our team at Mbryonics. As a key member of our technical staff, you will be responsible for planning, executing, and documenting validation activities for our complex hardware and software systems.ResponsibilitiesDevelop and execute design and validation plans for...
-
Senior Validation Engineer
2 weeks ago
Galway, Galway, Ireland GxP Recruitment Full timeThe requirements of this role within the wider project are to cover the validation activities with respect to the testing and manufacture of a new medical device.Role/ Responsibilities:Develop, and/or approve, validation documentation, including protocol, records, and reports.Performing and overseeing process and test method validation activities within the...
-
Sterilisation Validation Engineer
3 weeks ago
Galway, Galway, Ireland CareerWise Recruitment Full timeSTERILISATION VALIDATION ENGINEER required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime on-site role on an initial 12-month contract. The STERILISATION VALIDATION ENGINEER will support sterility assurance activities for new products and change control, developing strong partnering relationships with these...
