Validation Engineer - County Waterford

Validation Engineer - County Waterford.

In this role you will be responsible for creating and executing validation documentation and co-ordinating validation activities for moulding, assembly, testing equipment, computerised systems and facilities within the quality management system.

Key Responsibilities:
• Write the necessary validation plans, protocols, reports & amendments of the Quality Management System ensuring compliance with the latest Regulatory Agency (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 in and drive quality GMP audits.
• Knowledge and use of LEAN 6 sigma tools for problem solutions

Interested applicants should have:
• Degree in Engineering/Science discipline.
• At least 1 to 3 years’ experience in a Validation or Quality engineering role.
• Ideally knowledge of process validation and capability. Experience in method validation and process characterization is an advantage.

• 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.