We are seeking a highly experienced Principal Engineer to lead and provide technical expertise in Clean Utilities systems, GMP investigations, and deviation management/documentation. The ideal candidate will combine strong engineering fundamentals with deep knowledge of GMP regulations, root cause analysis, and quality systems. Key Responsibilities: Clean Utilities Oversight Provide technical leadership for clean utilities systems (e.g., WFI, clean steam, compressed air, purified water). Ensure systems operate in compliance with cGMP and regulatory requirements. Support lifecycle management including design review, commissioning, qualification, and ongoing monitoring. Drive improvements related to system reliability, efficiency, and compliance. GMP Investigations Lead complex deviation investigations using structured problem-solving methodologies (e.g., Root Cause Analysis, 5 Whys, Fishbone). Ensure timely, thorough, and inspection-ready investigation reports. Identify systemic issues ...