Requirements:

Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review. Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments. Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities. Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices. Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs. Strong analytical and problem-solving skills with exceptional attention to detail. Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines. Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders. Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment. Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred. 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments. Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.

Key Competencies:

Quality Validation & Compliance. CAPA Management. Regulatory Knowledge (FDA, GMP, GxP, QSR). Risk Assessment & Root Cause Analysis. Cross-Functional Collaboration. Project Management. Technical Documentation & Reporting. Continuous Improvement & Quality Excellence.