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-s...