Principal Engineer

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

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 Bachelor’s 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.