Qualification & Validation Engineer PQ

Drive validation excellence at the heart of Ireland’s cutting‑edge pharmaceutical manufacturing.

R&D Partners is seeking an experienced Qualification & Validation Engineer – Process Performance Qualification (PQ) to join a leading pharmaceutical company in Ireland. This role is critical in ensuring the successful delivery of process validation lifecycle activities (Stage 1, Stage 2, and Stage 3) for commercial manufacturing. The ideal candidate will have a strong background in process validation, regulatory compliance, and cross-functional collaboration.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Author, review, and execute PPQ protocols and reports in alignment with global standards and regulatory expectations.
• Define PPQ strategy, including batch numbers, sampling plans, acceptance criteria, and statistical approaches.
• Contribute to the development and maintenance of the Process Validation Master Plan (PVMP).
• Support lifecycle management changes requiring PPQ, including technology transfers and post-approval changes.
• Conduct risk assessments to evaluate process risks and define appropriate control strategies.
• Apply risk-based approaches to PPQ study design, sampling strategies, and acceptance criteria justification.
• Ensure timely closure of PPQ-related deviations and CAPAs before and after execution.
• Maintain accurate and audit-ready documentation throughout the validation lifecycle.
• Collaborate with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance teams to ensure alignment on PPQ strategy and outcomes.
• Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise.
• Provide training and technical guidance to operations personnel and cross-functional team members involved in PPQ activities.
• Design and execute Continued Process Verification (CPV) programs.

Key Skills and Requirements:

• Education: Degree in Science (e.g., Chemistry, Microbiology, or IT) or Engineering (Chemical, Mechanical, or Electrical disciplines).
• Experience: Minimum of 3-5 years in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment.
• Demonstrated hands-on experience in PPQ design, execution, and reporting.
• Proven track record of authoring and reviewing validation documentation, including protocols, reports, deviations, and change controls.
• Strong understanding of process validation principles and lifecycle approach.
• Knowledge of cGMP regulations, FDA 21 CFR Parts 210-211, EU GMP Annex 15, FDA Process Validation Guidance (2011), and EMA process validation requirements.
• Familiarity with ICH Q8, Q9, Q10, and Q11 guidelines.
• Proficiency in statistical methods applied to process validation (e.g., process capability, statistical sampling).
• Experience with deviation management, CAPA, and change control systems.
• Excellent project management skills with the ability to manage multiple priorities.
• Strong communication and influencing skills at all organizational levels.
• Strategic thinker with a pragmatic approach to balancing compliance and business needs.

For more information, please contact Jack Keens.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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