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.

Qualifications :

• Doctorate 2 years Engineering experience or
  Masters 4 years of Engineering experience or Bachelors degree and 8 years of experience in Engineering (Chemical Mechanical Industrial or related field.
• Bilingual (Spanish/English)(Speak/Write)
• Strong expertise in Clean Utilities systems within a GMP environment.
• Proven experience leading GMP investigations and deviation management.
• Deep understanding of FDA EMA and cGMP regulations.
• Exceptional technical writing skills for investigation and deviation documentation

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract