Acted as client representative overseeing processing engineering, calibration, and facility management. Led FDA submission processes for both the facility and drug product.Conducted comprehensive quality audits using FDA's risk-based approach. Identified gaps and provided actionable recommendations to enhance compliance and quality standards.Directed C&Q and Quality Validation for the CAR-T facility, Phase 2 buildout, and Quality Control Lab. Managed 240 systems and utilities, authored QMS validation documents, and optimized equipment assessment processes. Managed a $2.4M budget.Led cleaning validation for Line 9, ensuring compliance with regulatory standards. Directed comprehensive process validation, including development studies and batch recorder reviews.Provided SME guidance for process validation, including mixing studies and protocol execution. Conducted gap analyses and authored column resin lifetime studies/protocols.Conducted a comprehensive audit of the cleaning validation program, identifying areas for improvement and leading the development of corrective actions.Guided cleaning validation for OTC solids, developed QMS cleaning validation plans, and authored validation gap analysis reports.Executed IQ/OQ/PQ validation protocols for cold rooms and freezers, ensuring compliance with regulatory standards.Provided expertise for Cleaning Validation Master Plan and program for medical device manufacturing, implementing corrective actions and process optimizations.Conducted comprehensive quality gap analyses for process and cleaning validation, managing CAPAs, NCEs, and updating SOPs. Prepared detailed final reports on validation processes.Developed and validated the TOC method for Cleaning Validation in medical devices. Authored performance qualification protocols and reports.Led the assessment and re-validation of 100 pieces of equipment. Managed gap analyses, re-qualified non-compliant equipment, and oversaw document tracking and project updates.

• Leadership and Oversight: Directed comprehensive Cleaning and Process Validation initiatives, ensuring adherence to GxP standards across critical projects.• Client #5: Managed the construction and C&Q activities for a new manufacturing facility. Validated 82 systems and utilities, including complex robotic and EM isolator systems. Implemented single-use equipment strategies, improving operational efficiency and regulatory compliance. Delivered the project on time, within budget, and exceeding quality expectations.• Client #4: Conducted a thorough 3rd Party Quality Audit following FDA 483 Observations. Directed remediation efforts, including surface area calculations, worst-case soil evaluations, and cleaning cycle development. Revised the cleaning validation master plan and protocols to align with updated regulatory requirements.• Client #3: Provided expert consultation for the Kneat software implementation, digitizing validation, commissioning, and qualification processes. Collaborated with cross-functional teams to customize the software and conducted training to ensure effective adoption.• Client #2: Managed C&Q activities for a new manufacturing facility, covering 190 systems and utilities. Applied Quality Risk Management (QRM) to determine Environmental Monitoring (EM) locations for validation. Efficiently managed staffing and resources, delivering the project within budget and timeline constraints.• Client #1: Led Phase 1 construction and C&Q for a remodeled facility, establishing a robust Quality Management System (QMS). Directed validation efforts to ensure compliance with regulatory standards and industry best practices.

• Led validation projects, ensuring compliance with regulatory standards and developing tailored validation strategies for clients. Managed project teams and client relationships.• Client #2: Managed Quality FMEA for a penicillin manufacturing facility. Established corrective actions, led remediation efforts, and developed comprehensive reports.• Client #1: Oversaw project budgets and new developments, including cleaning validation activities for vaccine manufacturing. Managed a $2.5M budget and ensured regulatory compliance.

Managed cleaning validation for multiple manufacturing facilities. Developed and executed cleaning validation protocols, supervised team members, and established robust QMS for Cleaning Validation.

Designed and executed stability studies and process validation for various manufacturing processes. Conducted cleaning validation and facilitated production and QC testing.