• Led completion of effective CAPA investigations assuring compliance, quality, and on-time delivery of records. • Conducted thorough and structured investigations through data collection, cross-functional collaboration, root cause analysis tools and general problem-solving techniques to determine product impact.• Developed, managed, and tracked effectiveness of corrective action plans.

• Managed validation activities with a focus on Autoclaves, Steam-In-Place (SIP), Bulk Heat Sterilization (BHS) and Ethylene Oxide Sterilization (ETO). • Authored protocols that challenge the critical process parameters and are aligned with current site procedures and regulatory requirements to ensure compliance. • Executed validation protocols, perform data analyses, and author validation summary reports.• Reviewed and approve validation documentation, protocols, and summary reports.• Resolved protocol deviations with effective corrective actions and root cause determination. • Responsible for performing equipment, facilities, and computer systems Periodic Reviews to ensure they remain in a qualified state and suitable for use after ongoing operation, maintenance, or modifications.• Served as Subject Matter Expert (SME) providing sterilization technical knowledge for corporate audits, new drug applications (NDAs) and DEKRA Certification.• Performed Technical Assessments for Change Controls and CAPA Investigations.

• Managed validation activities with a focus on Autoclaves, Steam-In-Place (SIP), Bulk Heat Sterilization (BHS) and Ethylene Oxide Sterilization (ETO). • Authored protocols that challenge the critical process parameters and are aligned with current site procedures and regulatory requirements to ensure compliance. • Executed validation protocols, perform data analyses, and author validation summary reports.• Reviewed and approve validation documentation, protocols, and summary reports.• Resolved protocol deviations with effective corrective actions and root cause determination. • Responsible for performing equipment, facilities, and computer systems Periodic Reviews to ensure they remain in a qualified state and suitable for use after ongoing operation, maintenance, or modifications.• Served as Subject Matter Expert (SME) providing sterilization technical knowledge for corporate audits, new drug applications (NDAs) and DEKRA Certification.• Performed Technical Assessments for Change Controls and CAPA Investigations.

• Supported new equipment installations to ensure that commissioning and validation reports/documentation is in accordance with cGMPs and applicable regulations. • Ensured sterilization process validation activities are performed and documented in compliance with GMPs and applicable regulations.• Provided support to investigations of validation failures and ensured are completed thoroughly and documented accurately.• Reviewed and approved procedures (SOPs) to ensure compliance with regulatory requirements and effectiveness of the Quality System.

• Redesigned and revised Lock Out/Tag Out (LOTO) instructions to include information of all the equipment’s energy magnitudes and developed a guideline to standardize/simplify the revision, this ultimately impacted the entire Site.• Implemented operator manufacturing rules in over 75% of the Purification area reducing offset time by 15%.• Modified the Purification area staff training methodology by creating a Self-Study Training system focused on minor changes resulting in faster training completion