Principal Engineer
The Principal Engineer provides leadership and advanced technical expertise in the coordination and execution of multiple, complex, and non-routine engineering projects.
This role supports the planning, design, reconfiguration, construction, maintenance, and optimization of systems, facilities, and processes. The position applies deep, cross-functional engineering knowledge (process, unit operations, and equipment) to lead process characterization, optimization, scale-up, and manufacturing support initiatives that drive high-priority business goals.
Key Responsibilities
Establish and implement engineering policies for major organizational segments.
Interpret, execute, and recommend improvements to company-wide engineering standards.
Serve as a corporate engineering resource with expertise across multiple disciplines.
Lead and coordinate cross-functional engineering efforts aligned with business objectives.
Lead multiple large-scale, complex engineering and capital projects.
Develop and manage project and departmental budgets across all disciplines.
Plan, organize, and coordinate work of engineers, technicians, and cross-functional teams.
Ensure projects are delivered on time, within budget, and in compliance with quality standards.
Drive initiatives that significantly contribute to organizational priorities and performance.
Apply advanced engineering principles, theories, and concepts to develop innovative solutions.
Conduct in-depth investigations, define project scope, and develop novel engineering approaches.
Lead process characterization, optimization, and scale-up activities.
Design, execute, and implement complex engineering and process improvement projects.
Support manufacturing operations through technical expertise and troubleshooting.
Partner with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
Lead development of requirements and recommendations for complex system, facility, or process modifications.
Ensure alignment across departments for successful project execution.
Ensure compliance with cGMP, GLP, and regulatory requirements.
Support validation activities, including protocol development and execution.
Maintain and review documentation in highly regulated environments.
Required Skills & Competencies
Strong technical expertise across multiple engineering disciplines (process, equipment, utilities).
Proven leadership and team management capabilities.
Advanced problem-solving and analytical skills.
Strong project and program management experience.
Ability to manage budgets and financial aspects of projects.
Excellent communication, technical writing, and presentation skills.
Ability to work independently and lead complex initiatives.
Strong collaboration and stakeholder management skills.
Requirements
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
Preferred Qualifications
Degree in Mechanical or Chemical Engineering.
Experience in pharmaceutical or biotech manufacturing environments.
Working knowledge of:
cGMP and GLP regulations
Validation processes and lifecycle
Documentation practices in regulated industries
Highly Preferred Experience
Hands-on experience with Clean Utility Systems, including:
Purified Water (PW)
Water for Injection (WFI) / Distilled Water
Reverse Osmosis (RO) systems
Experience with Clean Gases systems:
Process Air
GMP gases (Oxygen, Nitrogen)
Experience managing and documenting:
Deviations (Non-conformances)
SOP development and process improvements
Experience working in:
Critical operations environments
Capital project execution
Benefits
Administrative Shift & Non-Standard Shift
1- year contract