QA Validation Specialist

Role overview

The QA Validation Specialist will provide site-wide compliance oversight for validation activities at Pfizer’s Grange Castle plant in Dublin. This position also offers technical quality assurance support to Engineering, Automation, Technical Operations, Technical Services, Business Technology, and QC. The assignment is an 11-month fixed-term contract with a hybrid working arrangement.

Key responsibilities

• Monitor qualification and validation work, including re-validation where needed, by assessing and approving documentation for equipment, utilities, control systems, cleaning validation, and related areas.
• Make sure activities remain aligned with company standards, internal procedures, regulatory expectations, and industry requirements, while keeping training up to date.
• Advise Engineering, Automation, BT, Technical Operations, Technical Services, and QC on quality and compliance matters.
• Support cross-functional project groups by advising on validation regulations, strategy, and implementation approach.
• Contribute to Quality Risk Management and Operational Excellence efforts that aim to improve efficiency and strengthen continuous improvement.
• Evaluate and approve validation protocols, procedures, specifications, reports, deviation records, and project plans as required.
• Review policies and master plans.
• Ensure change controls and automation change requests follow the correct procedures and preserve the validated state.
• Help release equipment, utilities, facilities, and computer systems in a timely manner after validation work is completed.
• Take part in site self-inspections, internal audits, board of health audits, and third-party audits.
• Support Biotech Communities of Practice and Common Interest Groups when needed.
• Assist Operational Units, site projects, and cross-functional teams as required.

Requirements

• A BSc or engineering degree in a technical discipline is required.
• At least 2 to 3 years of experience working in a pharmaceutical environment is required.
• Strong written and verbal communication skills, along with good interpersonal ability.
• Capacity to work both independently and collaboratively in a fast-moving, dynamic environment.

Additional information

This role is based in Dublin, County Dublin, Ireland at a state-of-the-art plant in Grange Castle. It is a contract position for 11 months. The working model is hybrid. The source did not specify salary, stipend, number of vacancies, start date, or application deadline.