Senior Validation Professional- Medical Device

3 days ago

Dublin, Dublin City, Ireland Brightwater Capital, LLC Full time

Senior Validation Professional-Medical Device

About the Company

My client is a leading multinational medical device company, specializing 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 device manufacturing plant.

Key Responsibilities

  1. Lead and Manage the Validation Team: Oversee daily operations, allocate work, and ensure high performance and quality output.
  2. Drive Validation Projects: Serve as the lead on all validation projects, ensuring alignment with protocols and production requirements.
  3. Ensure Compliance: Develop strategies to meet regulatory requirements, maintain validation policies and procedures, and manage the Validation Master Plan.
  4. Lifecycle Management: Oversee product and process transfers, manage PFMEA and control plans, and support post-validation activities.
  5. Technical Execution: Lead IQ, OQ, PQ, and process development activities, including DOE and MSA, to ensure process effectiveness.
  6. Cross-Functional Collaboration: Work closely with Operations, Planning, and Engineering teams to validate manufacturing processes.
  7. Regulatory Audits: Participate in regulatory audits and ensure all validation activities meet industry standards.

Experience/Requirements

  1. Minimum 5 years of high-volume engineering experience in the medical device industry.
  2. 3+ years of experience in validation processes.
  3. BA/BS Engineering or related technical qualification.
  4. Proficient in statistical techniques, including Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes.
  5. Strong experience in process development, DOE, and risk management (FMEA).
  6. Excellent documentation skills and a strong understanding of process validation.
  7. Proven ability to lead a team, manage projects, and communicate effectively across departments.
  8. Strong problem-solving skills and the ability to work independently or as part of a team.

Remuneration Package

A competitive package is on offer which will include salary, benefits, and bonus.

Contact

For more information on this position or other life sciences roles, please contact Charlie Bigger or email, or simply click the apply button.

To view all live jobs with Brightwater and market insights, please visit our website:

Skills:
medical device, validation, equipment, process development, Leadership

#J-18808-Ljbffr

  • Medical Device Validation Specialist

    5 days ago

    Dublin, Dublin City, Ireland beBeeValidation Full time

    Senior Validation ExpertThe Senior Validation Expert plays a pivotal role in ensuring the quality and reliability of medical devices. This critical position involves executing design verification and validation testing to support product lifecycle management and new product development.The ideal candidate will have expertise in developing and qualifying test...

  • Senior Validation Professional

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    About the Role:">The Senior Validation Engineer will play a crucial role in ensuring the quality and safety of medical devices. This position involves executing design verification and design validation testing to support product lifecycle management and new product development.

  • Senior Medical Device Development Leader

    1 week ago

    Dublin, Dublin City, Ireland beBeeManager Full time

    Medical Device Program ManagerWe are seeking an experienced and motivated Program Manager to oversee and drive the success of strategic projects and initiatives within the medical device industry.Responsibilities:- Lead and manage multiple programs that span the lifecycle of medical device development, from ideation through design, development, and...

  • Senior Validation Manager

    1 week ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Overview of the RoleIn this pivotal position, you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at our site.You will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively.Responsibilities:As a team leader, you will be...

  • Senior Validation

    2 weeks ago

    Dublin, Dublin City, 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...

  • Pharmaceuticals and Medical Devices Expert

    6 days ago

    Dublin, Dublin City, Ireland beBeeAnalytical Full time

    Expertise in pharmaceuticals and medical devices is essential for our team. A successful candidate will possess knowledge of GMP-compliant analytics, pharmacopoeial methods, and ISO standards.Job DescriptionWe offer a unique opportunity to work with starting materials, in-process products, active substances, and finished pharmaceutical products using...

  • Senior Validation Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeValidation Full time

    About the RoleAs a Senior Validation Specialist, you will be responsible for executing design verification and design validation testing in support of product lifecycle management and new product development. Your primary objective will be to develop and optimize physical test methods and test fixtures to ensure the commercialization of new medical device...

  • Medical Device Developer

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Job Title:  Medical Device Developer Description:  We are seeking an experienced Medical Device Developer to lead the design and execution of testing strategies for Combination Products. About the Role:  In this position, you will utilize your expertise in drug delivery systems and medical device development to collaborate with multi-disciplinary teams...

  • Medical Device Development Leader

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Job DescriptionR&D Manager Job SummaryWe are seeking an experienced R&D Manager to lead our team in the development of innovative medical devices. The successful candidate will have a strong technical background, excellent leadership skills, and the ability to manage complex projects.Key Responsibilities:Recruit, manage, and develop senior and R&D engineers,...

  • Medical Device Project Leader

    1 week ago

    Dublin, Dublin City, Ireland beBeeManagement Full time

    Medical Device Project ManagerWe are seeking a seasoned Program Manager to lead and manage multiple projects within the medical device industry.The ideal candidate will have at least 3 years of experience in program management, specifically within the medical device industry or a closely related field. They will also possess a degree in Biomedical...