Summary
The Principal Engineer manages and applies extensive technical expertise in coordinating multiple complex engineering projects related to system design, reconfiguration, construction, maintenance, and process optimization. The role requires deep technical knowledge across multiple engineering domains, including process engineering, unit operations, and equipment/project engineering, with strong experience in manufacturing support, scale-up, and process characterization.
This position also plays a key role in establishing engineering standards, guiding cross-functional teams, and ensuring compliance with regulatory and quality requirements in a GMP-regulated environment.
Responsibilities
- Establish engineering policies and technical standards for a major segment of the organization
- Interpret, execute, and recommend updates to company-wide engineering policies and procedures
- Develop and manage large-scale project and organizational budgets across multiple disciplines
- Apply advanced engineering principles to develop innovative concepts and technical solutions
- Lead in-depth technical investigations, defining scope and conducting complex engineering studies
- Plan, organize, and coordinate work of engineers and technicians across multiple functions
- Lead cross-functional collaboration with manufacturing, R&D, process development, utilities, facilities, QA, and validation teams
- Define requirements and provide recommendations for large-scale system or facility modifications
- Serve as a senior engineering resource across multiple engineering disciplines
- Design, execute, and implement complex engineering and process improvement projects that support critical business objectives
- Other duties may be assigned as needed
Qualifications:
- Doctorate + 2 years of engineering experience OR Master’s degree + 4 years of engineering experience OR Bachelor’s degree in Engineering + 6 years of engineering experience
- Experience in clean utilities systems and GMP investigations
- Experience with deviation documentation in regulated environments
- Working knowledge of pharmaceutical or biotech manufacturing processes
- Familiarity with validation processes and protocol execution
- Experience in highly regulated environments (GMP/GLP)
- Ability to operate specialized laboratory or engineering equipment and systems
- Strong understanding of engineering application in production environments
- Ability to troubleshoot and solve technical problems of moderate scope
- Strong technical writing and documentation skills
- Excellent verbal and cross-functional communication skills
- Solid understanding of validation requirements and execution processes
Job Type: Full-time
Pay: $55.00 - $60.00 per hour
Education:
Experience:
- Clean Utilities (Distilled Water, Purified Water, RO Systems: 6 years (Preferred)
- laboratory or engineering equipment and systems: 6 years (Preferred)
- troubleshoot and solve technical problems: 6 years (Preferred)
- technical writing and documentation: 6 years (Preferred)
- GMP investigations : 6 years (Preferred)
- validation processes: 6 years (Preferred)
- protocol execution: 6 years (Preferred)
- biotech manufacturing processes: 6 years (Preferred)
- highly regulated environments (GMP/GLP): 6 years (Preferred)
- Clean-in-Place (CIP): 6 years (Preferred)
- Steam-in-Place (SIP): 6 years (Preferred)
- Clean Steam: 6 years (Preferred)
- Clean Compressed Air: 6 years (Preferred)
- Vacuum systems: 6 years (Preferred)
Work Location: In person
