· Author, review, and approve validation master plans (VMPs), protocols, reports, and risk assessments for formulation, fill/finish drug product manufacturing.

· Define critical process parameters (CPPs) and critical quality attributes (CQAs) in partnership with Process Development, tech transfer and Quality.

· Develop sampling plans and statistically justified acceptance criteria for PPQ campaigns.

· Establish and maintain CPV programs, including statistical process control, trending, and periodic reporting.

· Apply quality risk management tools (FMEA, HACCP, risk ranking) consistent with ICH Q9.

· Manage validation projects, including planning schedules, coordinating resources, monitoring progress, and ensuring timely completion.

· Execute field verification activities and oversee protocol execution while ensuring compliance with approved validation documentation.

· Review engineering/process flow drawings, P&IDs, equipment specifications, maintenance records, and history files to support qualification activities and maintain validated systems.

· Author and revise Standard Operating Procedures (SOPs), validation procedures, and technical documentation supporting validation lifecycle management.

· Participate in technology transfers, capital projects, equipment installations, and process improvements to ensure validation requirements are incorporated throughout project execution.

· Lead or support deviation investigations, change controls, risk assessments, root cause analyses, and Corrective and Preventive Action (CAPA) activities affecting validated systems.

· Work cross-functionally with Manufacturing, Quality Assurance, Quality Control, MSAT, Process Development, and Engineering.

· Serve as the Validation subject matter expert (SME) during customer audits, regulatory inspections, and cross-functional project meetings.

· Identify opportunities to improve validation processes, documentation, and execution through continuous improvement initiatives.

· Ensure all validation activities comply with company Quality Management System (QMS) requirements and applicable FDA, EMA, and international regulatory guidance.