Principal Scientist

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 and implement effective CAPAs (Corrective and Preventive Actions).
• Serve as a subject matter expert during regulatory inspections and audits.

Deviation Documentation & Quality Systems

• Author, review, and approve deviation reports, investigations, and technical justifications.
• Ensure documentation aligns with internal SOPs and FDA/EMA regulatory expectations.
• Drive improvements in documentation quality, consistency, and compliance.