Qualification & Validation Engineer – QA

Role Summary:

• We are seeking an experienced Qualification & Validation Engineer – QA to join our client’s Qualification and Validation Team based on their state-of-the-art biopharmaceutical site in Co. Waterford.
• In this critical role, you will be responsible ensuring that equipment, facilities, utilities, processes, and computer systems used in the manufacture of pharmaceutical products meet the highest standards of quality, compliance, and patient safety.
• Operating within the company’s Quality Assurance framework, this role is responsible for ensuring the design, execution, review, and approval of qualification and validation activities are in full compliance with GMP regulations and applicable regulatory guidelines (FDA, EMA, ICH).
• The specialist will work cross-functionally to support continuous improvement and ensure that all validation lifecycle activities are robust, science-based, and inspection-ready.

Core Duties and Responsibilities:

• Quality oversight of qualification and validation tasks in his/her area
• Preparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre- defined timelines.
• Ensuring proper documentation of deviations, non-conformances, and corrective actions.
• Ensuring proper evaluation (validation expertise) of change controls.
• Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards.
• Participating in internal and external audits and inspections, providing necessary documentation and support.
• Cooperating with cross-functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activities.
• Providing qualification and validation expertise when requested.
• Identifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiatives.

Minimum Qualifications and Experience:

• Degree in science (e.g. Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mech/Elec) discipline.
• Minimum 5+ years of experience in Validation and / or QA within the pharmaceutical/biotech industry.
• Strong understanding of process validation principles and lifecycle approach; Understanding of cGMP regulations: FDA 21 CFR Parts 210/211, EU GMP Annex 15, FDA Process Validation Guidance (2011) and EMA process validation requirements, Working knowledge of ICH Q8, Q9, Q10, Q11 guidelines.
• Familiarity with qualification of equipment, utilities, and manufacturing systems.
• Strong knowledge of data integrity principles (ALCOA+).
• Experience with deviation management, CAPA, and change control systems.
• Proficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs)
• Excellent project management capabilities with ability to manage multiple priorities.
• Expertise in conducting risk assessments, analysing validation data, and resolving deviations and non-conformances
• Natural influencer and works well as part of a multifunctional team.
• Highly motivated and self-resilient.
• Adaptable and flexible as well as a pragmatically minded problem solver.
• Excellent communication skills to effectively collaborate with cross-functional teams
• Strategic thinking with focus on balancing compliance requirements with business needs.

Please note, we do not require agency assistance with this role.