Senior Validation

4 weeks ago

clare claremorrisswinford municipal district ireland Beckman Coulter Instruments Full time

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

The Senior Validation and Verification Engineer for Beckman Coulter Diagnostics is responsible for leading and managing process validation activities in the Co. Clare facility.

This position is a 9 month contract, part of the Validation Department located in the Beckman Coulter facility in Lismeehan, O'Callaghans Mills, Co. Clare and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Validation team and report to the Manager Validation and Verification responsible for process validation activities. You will have responsibility for supporting multiple value streams on site, managing and executing defined validation strategies for the implementation of new products, processes and equipment. If you thrive in a fast-paced, multi-functional team role and want to work to build a world-class Quality organization—read on.

In this role, you will have the opportunity to:

  • Develop and maintain site master validation plan, procedures, work instructions and templates in line with corporate and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities.
  • Lead, integrate & project manage validation tasks and develop strategies on all validation projects with multifunctional project teams ensuring project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.
  • Provide guidance and support to all departments to ensure they understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines.
  • Prepare, review and execute site validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards.
  • Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements.
  • Represent validation at both internal and external audits.

The essential requirements of the job include:

  • Bachelor's degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 5+ years experience in a highly regulated (FDA desirable) healthcare or related environment, or Master's degree with a minimum of 3+ years' experience, or Doctoral degree with 0-2 years experience.
  • Managing change effectively to better serve customers in a busy environment, with demonstrated ability to multi-task and deliver to agreed timelines.
  • Good knowledge of ISO13485, FDA & GMP standards.
  • Understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
  • Strong interpersonal and communication skills with the ability to influence.

It would be a plus if you also possess previous experience in:

  • Analytical data analysis, e.g., Minitab.

Skills:
Validation, Process Validation, Equipment Validation, Change Controls, Validation Engineer

Benefits:
Pension Fund, Performance Bonus, Medical Aid / Health Care

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