Validation Engineer (Maternity Cover)
Jabil View all jobs
- Waterford
- Permanent
- Full-time
- 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.
- 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.
- 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.