Position Summary We are seeking a highly skilled and experienced
Principal Engineer to lead and support engineering initiatives in a regulated environment. This role requires strong technical expertise, leadership capabilities, and experience working with clean utilities and GMP systems.
Key Responsibilities - Provide technical leadership for engineering projects and operational support activities
- Ensure compliance with GMP regulations and industry standards
- Lead and support investigations, including deviations and root cause analyses
- Oversee and contribute to deviation documentation and corrective/preventive actions (CAPAs)
- Support design, operation, and maintenance of clean utilities systems
- Collaborate cross-functionally with Quality, Manufacturing, and other departments
- Drive continuous improvement initiatives and engineering best practices
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
- Bachelor's degree in Engineering or related field + 6 years of engineering experience
Preferred Qualifications - Experience working with Clean Utilities systems (e.g., WFI, clean steam, compressed air, etc.)
- Strong knowledge of GMP regulations and compliance requirements
- Experience in GMP investigations and deviation management
- Proficiency in deviation documentation and root cause analysis
- Excellent problem-solving and communication skills
