Validation Engineer

1 week ago

Waterford, Waterford, Ireland ICDS Recruitment Full time

Job Description

Validation Engineer - County Waterford

Ref No: AM18521

County Waterford, Republic of Ireland

Competitive salary

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 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.

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