Job Summary: We are currently seeking an experienced Qualification & Validation Engineer to join a high-performing validation team within a leading pharmaceutical organisation. This is a key role focused on leading Process Performance Qualification (PPQ) activities across the full process validation lifecycle, ensuring manufacturing processes are robust, compliant, and capable of consistently delivering high-quality products in line with global regulatory standards. Responsibilities Lead and execute Process Performance Qualification (PPQ) activities in line with global quality standards and regulatory requirements Author, review, and approve PPQ protocols and reports Define PPQ strategies including batch selection, sampling plans, acceptance criteria, and statistical methodologies Contribute to and maintain the Process Validation Master Plan (PVMP) Support lifecycle validation activities including technology transfers and post-approval changes Perform and contribute to risk assessments to identify process risks and define control strategies Apply risk-based approaches to PPQ design and execution Ensure timely investigation and closure of deviations, CAPAs, and change controls Maintain accurate, audit-ready documentation throughout the validation lifecycle Collaborate cross-functionally with MSAT, Manufacturing, QC, and QA teams Ensure compliance with cGMP, FDA, EMA, and ICH guidelines Support regulatory inspections and internal audits Provide technical guidance and training to cross-functional teams Design and support Continued Process Verification (CPV) programs Requirements Degree in Science (e.g. Chemistry, Microbiology) or Engineering (Chemical, Mechanical, Electrical or similar) 35+ years experience in pharmaceutical manufacturing, validation, or quality within a GMP-regulated environment Hands-on experience in PPQ design, execution, and reporting Proven experience authoring and reviewing validation documentation Strong understanding of process validation lifecycle principles Knowledge of cGMP regulations including FDA 21 CFR Parts 210/211, EU GMP Annex 15, and relevant FDA/EMA guidance Familiarity with ICH Q8, Q9, Q10, and Q11 guidelines Experience applying statistical methods to process validation Understanding of equipment and system qualification Experience with deviation management, CAPA, and change control systems Strong project management and organisational skills Excellent communication skills with the ability to influence stakeholders Collaborative mindset with the ability to work effectively across multifunctional teams Adaptable, solutions-focused, and proactive approach to problem-solving #LI-PC2 Skills: PPQ Process Validation Deviations CAPA PVMP