Validation Lead
7 months ago
Team Horizon is seeking a Lead Validation Engineer Lead for our client’s manufacturing facility in the West of Ireland. In this role you will lead a team to successfully deliver the validation programme of activities in support of manufacturing operations and coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.
Why you should apply:
Join a company who are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
Be part of a diverse, inclusive and authentic workplace that offer competitive salaries, benefits & career progression opportunities
What you will be doing:
You will be responsible for providing validation oversight and take full ownership of the validation requalification and/or projects supporting the manufacturing operations.
Lead a team of Validation Engineers in the completion of validation activities providing guidance and direction in the preparation and execution of validation activities, such as process validation, equipment/utilities/facilities qualification, sterilization validation and cleaning validation.
Act as a key member of multi-department teams as the Validation Subject Matter Expert (SME) bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
Lead validation efforts with cross functional teams to deliver Validation projects and to schedule.
Support in execution of validation/qualification studies when required.
Contribute in areas such as regulatory submissions, change control, periodic review, investigation/deviation management, CAPA’s, policy writing and Validation Master Plan’s.
Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Management.
Conduct validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies and EHS requirements.
Support and develop direct reports to ensure their training and development needs are met and encourage their continued growth within the organisation.
Perform other duties when required.
What you need to apply:
Minimum of a Bachelor's degree (or equivalent) in Science or Engineering and 5+years’ experience in a pharmaceutical or medical device manufacturing facility.
Experience of people management and project management will be a distinct advantage.
Must possess knowledge of pharmaceutical and/or medical device regulatory requirement for FDA and IMB regulated environments.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
-
EMC Validation Engineer
6 months ago
Galway, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription EMC validation Engineer Team Horizon is seeking a 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, it runs the activities for one project according to company rules and international...
-
Galway, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...
-
Sterilization and Microbiology Engineer
6 months ago
Galway, Ireland Celestica Full time08 - Specialist, Operations Quality Req ID: Remote Position: No Hiring Manager: Pat Murphy Band: 08 Region: Europe Country: Ireland State/Province: Galway City: Galway General Overview Functional Area: Quality (QUA) Career Stream: Operations Quality (OPQ) Role: Specialist (SPE) Job Title: Specialist, Operations Quality Job Code...
-
Collins McNicholas | NPI Engineer
2 days ago
Galway, Ireland Collins McNicholas Full timeWe are partnering with a leading company in the medical device industry to recruit a New Product Introduction (NPI) Engineer. In this role, you will play a pivotal role in guiding the introduction of new products and driving product development projects from concept to commercialisation. This is an exciting opportunity to contribute to innovation and...
-
Galway, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve...
-
Development Engineer
7 months ago
Galway, Ireland STERIS Full timeAt STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary This role is positioned within the engineering team based at the STERIS Galway laboratory. The site provides testing and other technical services to the medical device...
-
Galway, Ireland TE Connectivity Germany GmbH Full timeWe are seeking a highly skilled Senior R&D / Product Development Engineer with expertise in product and process design, process optimization and scale-up. This role will be responsible for driving the development and implementation of processes from concept to transfer to production. The ideal candidate will possess extensive experience in process...
-
NPI Engineer
1 month ago
Galway, Ireland Pale Blue Dot® Recruitment Full timeOur Client, a leading MedTech company in Galway, is hiring an NPI Engineer to join their team.Responsibilities include but are not limited to:Supporting the Introduction of ISO56000, Innovation Management Standard.Execution of Freudenberg initiated projects within the Freudenberg Medical Group.Design & Development of New Products through the Customers...
-
Senior Research
3 months ago
Galway, Ireland Pale Blue Dot® Recruitment Full timeOur client, an exciting multidisciplinary medical device start-up based in Galway is hiring a Senior Research & Design Engineer. The successful candidate will report to the R&D Project Lead and will get the opportunity to apply engineering knowledge in areas such as design, test method development and validation, CAD and...
-
Galway, Ireland Stem Recruitment Partners Full timeStaff Process Development Engineer - Galway- Permanent role. Our client in Galway is seeking an experienced Staff Process Development Engineer to join their team. The ideal candidate will have experience working with Catheters, be available for a full-time onsite role, have an existing work permit/ visa for Ireland(Stamp 4 or EU passport) reside within a...
-
Senior Design Quality Engineer
7 days ago
Galway, Ireland CK Group Full timeSenior Design Quality Engineer Overview: CK QLS are recruiting a Senior Design Quality Engineer, to join our clients team for a 12-month project with potential extension. The role will be based in a hybrid setting in Galway, Ireland, with 3 days on-site work per week. The ideal candidate will have 5-8 years of experience in Quality Assurance for medical...
-
Galway, Ireland CareerWise Recruitment Full timeWe are seeking an experienced Staff Process Development Engineer for our Galway based client by CareerWise Recruitment This critical role will focus on designing, developing, and optimizing manufacturing processes for innovative medical devices, ensuring compliance with industry regulations. The role will further develop company methodologies to standardize...
-
Quality Engineer II
3 weeks ago
Galway, Ireland Pale Blue Dot® Recruitment Full timeOur Client, an exciting medical device start up in Galway City is hiring a Quality Engineer. The successful candidate will support process quality and design assurance. The level of seniority can be tailored to the expertise of the suitable candidate. Collaborating closely with R&D, Clinical, Regulatory, and Manufacturing Engineering teams, you will...
-
Principal R
3 months ago
Galway, Ireland Pale Blue Dot® Recruitment Full timeOur client a leading Medical device start up is hiring a Principal R&D EngineerResponsibilities include but are not limited to the following:Lead the development of the Company's novel device from clinical stage through to large scale manufactureLead the product brainstorming sessions to resolve design challenges and generate new responses to user...
-
Embedded Software Engineer
2 months ago
Galway, Ireland Pale Blue Dot® Recruitment Full timeOur client ,a leading Medical device startup is hiring an Embedded Software Engineer to lead the development of device firmware across a portfolio of products. Responsibilities include but are not limited to the following:Working with Design, Quality, Marketing and Clinical stakeholders to define and document firmware/software requirements. Collaborate...
-
Senior Software Engineer
8 months ago
Galway, Ireland arm limited Full timeThe Role The Arm Socrates IP Tooling team develops innovative software tools to facilitate the creation of sophisticated semiconductor Systems-on-Chip (SoC) based on Arm: CPU, GPU and System IP products. Our tools enable Arm Partners to quickly select, configure and integrate the IP components that make up their chips, greatly simplifying the process...
-
Cregg Recruitment | Process Technician
1 week ago
Galway, Ireland Cregg Recruitment Full timeCompany Information: CREGG Recruitment is currently seeking 2x Process Technicians for our client based in Athenry, Co. Galway. Our client is a leading manufacturer specialising in high-volume automated equipment. Operating from their European Manufacturing, Distribution, and Customer Service hub, they focus on delivering innovative solutions for the...
-
Quality Engineer
4 months ago
Galway, Ireland Abbott Full timeAbout Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160...
-
Hardware Design Engineer with Lab Eval Experience
7 months ago
Galway, Ireland Chipright Full timeHardware Design EngineerExperience Required:The candidate should have experience in some or all of the following areas: Low-power circuit design, DC/DC converters, power management methods, and analogue design and mixed-signal board-level design. Processor architecture, digital circuit design and embedded systems. Sourcing, evaluating & selecting...
-
Marketing Content Administrator
7 months ago
Galway, Ireland The Knot Worldwide Full timeMarketing Content Administrator Co. Galway, Ireland WHAT WE DO MATTERS: Here at The Knot Worldwide, we believe in doing work that matters. In more than 16 countries around the world, The Knot Worldwide’s leading family of brands—including The Knot, WeddingWire, Bodas, The Bash, The Bump, and more—help people take celebration planning from...