Validation Engineer

QCS Staffing Ltd; Dublin; On-site; EUR 40,000 - 60,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a Validation Engineer for a 9-month contract in Dublin, Ireland. The role involves supporting site validation activities, implementing compliance protocols, and assisting with global regulatory submissions within a leading pharmaceutical environment.

The ideal candidate will have significant experience in a pharmaceutical or biotechnology company and hold a Bachelor's degree in a relevant scientific field. This position offers an opportunity to contribute to cutting-edge drug development and manufacturing processes.

Qualifications

• Extensive experience with a pharmaceutical or biotechnology company.
• Experience with Facility, Utility, and Equipment qualifications.
• Prior experience with upstream cell culture and/or downstream formulation processes.

Responsibilities

• Support the site validation activities across multiple workstreams.
• Implement/maintain EM protocols and procedures for compliance.
• Support global regulatory submissions and audits as needed.

Skills

Experience with regulatory requirements

Knowledge of Good Manufacturing Practices

Experience in Facility and Equipment qualifications

Education

Bachelor’s degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry

Job description

Validation Engineer - Ireland, Dublin - 9 Month Contract

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting‑edge drugs.

What you’ll do

• Support the site validation activities across a number of workstreams.
• Support site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
• Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent requalification/revalidation.
• Support global regulatory submissions, internal audits and external inspections/audits as needed.

What you’ll need

• Extensive experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
• Experience in Facility, Utility and Equipment qualifications. Examples include CTUs, Parts Washers, Autoclaves, Clean Utilities, Cleanrooms/HVACs etc.
• Prior experience with upstream cell culture and/or downstream formulation/fill finish processes.