Job Description

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