Senior Validation Engineer

7 hours ago

Dublin, Ireland Embecta Full time

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. The Senior Validation Engineer will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at our Dun Laoghaire site. In this pivotal role, you will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively. Additionally, you will drive continuous improvement initiatives to enhance processes and maintain the highest quality standards. Responsibilities: Be a team leader within the validation team for all technical and equipment validation projects in line with predetermined protocols and production requirements. Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements. Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development and DOE activities Produce and maintain appropriate and comprehensive validation policy and procedures. Ensure execution of allocated validations according to the plant Validation Master Plan. Provide input, monitor and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews. Write and implement validation system documentation as required. Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently As a member of the Quality group, to liaise with Operations, planning and Engineering groups to ensure successful validation of all manufacturing processes. Plant SME for Process Validation Execution Manage the activities of a defined team of Validation Engineers. Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties Draft and Approve protocols and reports as required. Execution of IQ, Process Development, OQ and PQ on new/revised processes as required Local use of Validation Toolkits Publish site specific progress reports as required. Create and control PFMEA and control plans throughout product life cycle. Participate in regulatory audits and inspections. To link with Post Validation activities including closure of ACR and ECO (Change Control). Support site change control procedures. Experience and Education BSc / BEng or a similar relevant technical degree A minimum of 5 years high volume engineering experience in a Medical Devices. A minimum of 3 years validation experience Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes Process development experience (DOE's etc) Risk Analysis/Risk Management, FMEA's, etc. Strong documentation skills Ability to work on own initiative and as part of a team. Strong interpersonal and communication skills. Process validation training and experience Strong technical and problem-solving skills. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

  • Senior QA Specialist

    6 days ago

    Dublin, Ireland Life Science Consultants (LSC) Full time

    LSC have a great contract opportunity for a Senior Quality Assurance Specialist (Validation) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7 years of experience working in the pharmaceutical or biotechnology industry and are ready for...

  • Senior Validation Professional- Medical Device

    7 hours ago

    Dublin, Ireland Brightwater Full time

    Senior Validation Professional-Medical Device About the Company My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life. About the Position This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical...

  • Senior QA Validation Specialist

    7 days ago

    Dublin, Ireland PE Global Full time

    Description: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...

  • Validation Engineer

    7 days ago

    Dublin, Ireland Claran Consultants Ltd Full time

    This is what you will do: The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject...

  • ▷ High Salary! Validation Engineer New

    7 hours ago

    Dublin, Ireland CPL Full time

    On behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position site based in North Wicklow/South Dublin. Reports to Maintenance, Engineering and Validation Manager Essential responsibilities - Compilation and execution of validation protocols - Compilation of...

  • QA System and Validation Specialist

    7 days ago

    Dublin, Ireland Cpl Resources Full time

    The SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...

  • QA System and Validation Specialist

    7 hours ago

    Dublin, Ireland Cpl Resources Full time

    The SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...

  • Senior Automation Engineer

    7 hours ago

    Dublin, Ireland Embecta Full time

    embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...

  • Senior Human Factors Engineer

    7 hours ago

    Dublin, Ireland Life Science Recruitment Ltd Full time

    Senior Human Factors Engineer Our client a high potential start up are currently seeking a Senior Human Factors Engineer to join their team. Reporting to R&D Director Senior Human Factors Engineer will be responsible developing user requirement for device Role/Responsibilities: Lead the human factors process of the for a novel medical device, in compliance...

  • Senior Electrical Engineer

    7 hours ago

    Dublin, Ireland INFORM3 Recruitment Full time

    Senior Electrical Engineer (Associate Level)Dublin/Hybrid€100-110k Our client is an M&E Consultancy based in Dublin who are looking for Senior/Associate Electrical Building Service Engineers to join their team. The successful candidate will play a role in providing design delivery and integration of projects across the bid, design, installation and...

  • Cleaning Validation Specialist

    7 hours ago

    Dublin, Ireland CPL Full time

    CLEANING VALIDATION SPECIALIST Cpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term contingent contract at their state of the art plant in Dublin Grange Castle. Job Purpose: Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...

  • Senior Electrical Engineer

    7 hours ago

    Dublin, Ireland Kirby Group Engineering Full time

    Senior Electrical Engineer | West Dublin Permanent position available with a considerable portfolio of works for the next 5+ years To build your career by assisting in the delivery of 'leading edge' engineering projects. To work with a vibrant, agile and multi-functional team in delivering projects on time, safely, to budget and to the required quality...

  • [Apply in 3 Minutes] Hardware Validation Engineer, Ring Vietnam Development Center

    19 hours ago

    Dublin, Ireland Amazon Full time

    Hardware Design Engineer, Amazon Ring Vietnam Design Center Job ID: 2794284 | Amazon Corporate Services Vietnam Company Limited Ring is a leader in developing security products, such as Video Doorbells, Spotlights, and Cameras. Our Product Integrity team aims to develop reliable and robust products that delight our customers. Ring is seeking a Hardware...

  • Senior Site Engineer

    7 hours ago

    Dublin, Ireland SRG Full time

    Senior Site Engineer - Dublin Manages the engineering function as the senior representative, co-ordinates with the line manager and provides Engineering Leadership for their respective project. Sets the strategy for Engineering setting out and onsite control, along with the (Engineer/Assistant Engineer) and subordinates/supply chain. Is the primary point of...

  • (12/25/2024 A) Senior Mechanical Engineer

    7 hours ago

    Dublin North, Ireland FRS Recruitment Full time

    Senior Mechanical Engineer Dublin Are you ready to shape the future of healthcare? Our client, a global leader in medical technology, is looking for an experienced Senior Mechanical Engineer to join their Diagnostics team. This is a fantastic opportunity for an ambitious engineer seeking to take the next step in their career. The position: In this role,...

  • Senior Mechanical Engineer

    7 hours ago

    Dublin, Ireland Siemens Healthineers Full time

    Senior Mechanical EngineerNow's our time to inspire the future of healthcare together.Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the...

  • Senior Engineer

    19 hours ago

    Dublin, Ireland Global Professional Consultants Full time

    Senior Engineer A well-established Main Building Contractor is seeking a Senior Engineer to work on a Commercial Refurbishment Project in Lucan, Dublin. Duties: Ensure calculations in plans, drawings, and quantity measurements are precise and accurate. Interpret and manage design documents received from the client or architect. Work closely with consultants,...

  • Senior Systems Analyst

    7 hours ago

    Dublin, Ireland Jones Engineering H.A. O'Neill Full time

    Position: Senior Systems Analyst Location: Head Office, Dublin 4 Company Description We are a leading engineering services company with a proven track record of high quality, customer focused project delivery for over 130 years. Our core divisions include Mechanical Engineering, Electrical Engineering, Sprinkler and Fire Protection. Some of the other...

  • ▷ (Apply in 3 Minutes) Senior Design Verification Engineer

    7 hours ago

    Dublin, Ireland Stem Recruitment Partners Full time

    STEM Recruitment Partners are working with a medical device org, based in Dublin, that is seeking an experienced Senior Design Verification Engineer to join their R&D operations. This role focuses on verifying medical device projects to ensure comprehensive validation throughout development, readiness for formal testing, and effective lab management of...

  • Project Engineer

    7 hours ago

    Dublin, Ireland Team Horizon Full time

    Project EngineerTeam Horizon is seeking a Project Engineer for a leading pharmaceutical company based in West Dublin. Supporting the Capital Projects Team with site-based projects for Oral Solid Dose Manufacturing, Facilities and Packaging operations.Why you should apply: * You enjoy working on exciting projects and want to work with a global manufacturing...