Qualification & Validation Engineer

• 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.
• Develop / Participate in 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 prior to and following PPQ execution.
• Maintain accurate and audit-ready documentation throughout the validation lifecycle.
• Work closely with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance to ensure alignment on PPQ strategy, execution, and outcomes.
• Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines.
• Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise.
• Provide training and technical guidance to operations personnel, validation associates, and cross-functional team members involved in PPQ activities.
• Design and execute Continued Process Verification (CPV) programs

• Degree in science (e.g. Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mech/Elec) discipline
• Minimum 3–5 years of experience in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment
• Demonstrated hands-on experience in Process Performance Qualification (PPQ) design, execution, and reporting
• Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls)

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