Qualification & Validation Engineer New

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.

• 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

• Degree in Science (e.g. Chemistry, Microbiology) or Engineering (Chemical, Mechanical, Electrical or similar)
• 3–5+ 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

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