Overview
Jabil Waterford, County Waterford, Ireland
Join to apply for the Validation Engineer role at Jabil
Jabil Waterford, County Waterford, Ireland
6 days ago Be among the first 25 applicants
Join to apply for the Validation Engineer role at Jabil
Responsibilities
* 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.
* 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 solution.
* Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
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.
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