Validation Engineer

4 weeks ago

Waterford, Waterford, Ireland Jabil Full time

Jabil Waterford, County Waterford, Ireland

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Jabil Waterford, County Waterford, Ireland

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Join to apply for the Validation Engineer role at Jabil

We are looking for an experienced

Validation Engineer

to join our team in Waterford, Ireland.

Learn more about Jabil in Waterford -> JABIL | WATERFORD | JOIN US - Jabil (beamery.com)

The validation engineer shall be responsible for creating and executing validation documentation and coordinating validation activities for moulding, assembly, testing equipment, computerized systems and facilities within the quality management system.

Key Responsibilities and End Results:

  • Write the necessary validation plans, protocols, reports & amendments of the Quality Management System ensuring compliance with the latest Regulatory Agencies (HPRA, FDA) directives / requirements within the Medical Device and Pharma Sector.
  • Generate applicable quality documentation in conjunction with validation activities.
  • Liaise within a cross functional team, to provide and drive validation inputs and initiatives into the overall operational activities of the company.
  • Liaise with external vendors for validation plans and requirements.
  • Development of validation projects, master validation plans.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Perform and generate risk assessment documents for regulated processes within the scope of the QMS.
  • Participate and drive quality GMP audits.
  • Knowledge and use of LEAN 6 sigma tools for problem solutions

Job Specifications:
  • Degree in Engineering/Science discipline.
  • 3 to 5 years' experience in a Validation or Quality engineering role.
  • Strong working knowledge of process validation and capability. Experience in method validation and process characterization is an advantage.

Skills/Attributes:
  • Strong working knowledge of validation and quality principles and practices with key emphasis on EudraLex, ISO13485, ISO14644, GAMP5 and FDA Pharma and medical devices regulations.
  • Ability to work in a cross functional team environment, with excellent initiative, decision-making and drive for achieving results.
  • Excellent technical report writing, time management, computer & presentation skills.
  • Excellent interpersonal and communication skills.

, BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesAppliances, Electrical, and Electronics Manufacturing

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