Position Summary
We are looking for an experienced and driven
Principal Engineer to provide technical leadership and support engineering activities within a regulated environment. The ideal candidate will possess strong expertise in engineering systems, regulatory compliance, and investigation processes, with the ability to lead complex initiatives and drive continuous improvement.
Key Responsibilities - Lead and support engineering projects, ensuring technical excellence and timely execution
- Provide subject matter expertise for clean utilities systems and related infrastructure
- Ensure adherence to GMP regulations and company quality standards
- Lead and support deviation investigations, root cause analysis, and CAPA implementation
- Author, review, and approve technical documentation, including deviation reports
- Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams
- Drive continuous improvement initiatives and implement best engineering practices
- Mentor and guide junior engineers and technical staff
Minimum Qualifications - Doctorate (PhD) in Engineering or related field + 2 years of engineering experience, OR
- Master's degree in Engineering or related field + 4 years of engineering experience, OR
- Bachelor's degree in Engineering or related field + 6 years of engineering experience
Preferred Qualifications - Experience with Clean Utilities systems (e.g., WFI, clean steam, HVAC, compressed gases)
- Strong knowledge of GMP regulations and compliance requirements
- Experience performing GMP investigations and managing deviations
- Proficiency in deviation documentation and root cause analysis
- Strong analytical, problem-solving, and communication skills
