QA Validation Specialist – Equipment, Utilities, 6 mth contract

Cashel - Ireland

Monthly Salary: Not Disclosed

Experience Required: 5years

Posted on: 30-10-2025

Vacancies: 1 Vacancy

Job Summary

QA Validation Specialist Equipment Utilities 6 mth contract

Summary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements company policy and procedures. Support to production / engineering to ensure the qualified state of equipment systems facilities and utilities are maintained.

Essential Duties and Responsibilities include but are not limited to the following:

Review and approve qualification and requalification protocols (IQ/OQ/PQ) for equipment systems facilities and plant utilities.

Support and oversee execution of qualification activities including area and drawing walkdowns and vendor interactions (e.g. FAT).

Review and approve related documents such as User Requirement Specifications SOPs drawings and support files.

Provide QA oversight and subject matter expertise on qualification validation and computerized system validation (CSV) activities including data integrity compliance.

Lead investigations into qualification-related deficiencies and drive corrective and preventive actions.

Approve calibration preventive maintenance (PM) activities and associated work orders for qualification activities

Support internal and external audits (e.g. FDA HPRA) and ensure ongoing audit readiness.

Promote continuous improvement initiatives within validation and contribute to performance KPI reporting.

Assist with training of QA and validation personnel and maintain validation documentation and archive systems.

Education & Experience:

Bachelors degree in Science or Engineering (or equivalent) with 5 years of experience in a pharmaceutical QA validation role.
Strong understanding of EU and FDA regulations related to equipment facility and computerized system qualification.
Knowledge of Data Integrity Good Documentation Practice (GDP) and validation lifecycle principles.
Excellent written and verbal communication organizational and interpersonal skills.
Demonstrated ability in protocol/report writing problem solving and cross-functional collaboration.
Eligible to work in Ireland.

Required Skills:

Technical / Functional Skills Equipment & Utilities Qualification: Proficient in IQ/OQ/PQ protocol review approval execution and requalification of equipment systems facilities and plant utilities. Computerized System Validation (CSV): Strong knowledge of GAMP 5 data integrity and validation of computerized systems. Regulatory Compliance: Deep understanding of EU GMP Annex 15 FDA 21 CFR Part 11 ICH guidelines and audit readiness requirements. Validation Lifecycle & Documentation: Skilled in creating/reviewing URS SOPs engineering drawings protocols reports and maintaining validation archives. Calibration & Maintenance Oversight: Ability to approve and oversee calibration preventive maintenance and associated work orders for qualified systems. Deviation & CAPA Management: Lead investigations into qualification deficiencies drive corrective/preventive actions and ensure continuous compliance. Audit Support: Experience supporting internal/external audits ensuring regulatory compliance and documentation readiness. Process Improvement: Promote continuous improvement within validation processes and contribute to KPI tracking. Soft Skills / Interpersonal Abilities Analytical & Problem-Solving: Strong capability to interpret validation data identify issues and implement solutions. Communication: Excellent written and verbal skills for reports investigations cross-functional interactions and training. Collaboration & Teamwork: Experience coordinating with production engineering QA and validation teams. Organizational Excellence: Efficiently manage multiple projects maintain accurate documentation and ensure compliance with GDP and ALCOA principles. Training & Mentoring: Ability to train and guide QA and validation personnel in procedures and best practices. Attention to Detail & Compliance Mindset: Rigorous adherence to regulatory requirements company policies and quality standards.

Required Education:

Bachelors degree in Science or Engineering (e.g. Chemistry Microbiology Mechanical Electrical or Chemical Engineering).Minimum 5 years of experience in a pharmaceutical or biotech QA validation to work in Ireland.

QA Validation Specialist Equipment Utilities 6 mth contractSummary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements company policy and procedures. Support to production / engineering t...