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.
Other open roles at QRC Group, Inc(6)
Key team members
Gilbert González
Mayra Nales Alvarez
Zulma Sanchez
Diosdado Viera Hornedo
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