Principal Engineer – HVAC, Clean Utilities & Process

Position Summary

The Principal Engineer – HVAC, Clean Utilities & Process serves as a site-wide technical expert and subject-matter expert for GMP HVAC systems, clean utilities, manufacturing systems, and process engineering. This role provides technical leadership across strategic and complex capital projects, operational initiatives, quality investigations, risk management activities, and asset life-cycle assessments. The Principal Engineer works independently within a matrix organization to develop and implement robust engineering solutions that support safe, compliant, reliable, and efficient biologics manufacturing operations. The role also provides coaching and technical development for engineers, technicians, interns, and contractors while supporting departmental objectives and continuous improvement.

Technical Leadership and Subject-Matter Expertise

• Serve as the recognized technical expert for HVAC, clean utilities, process systems, and related manufacturing systems across the site, including buildings, internal systems, and external infrastructure.
• Provide subject-matter expertise in clean utility systems, including Water for Injection (WFI), pure steam, OFCA, and specialty gases.
• Provide subject-matter expertise in GMP HVAC systems, cleanroom design, cleanroom operation, environmental control, and associated compliance requirements.
• Apply advanced knowledge of commercial biologics manufacturing operations, including bioreactors, centrifuges, formulation, column packing, utilities, automated systems, equipment, and general site operations.
• Serve as a technical expert and engineering representative on large capital projects from the concept and design phases through execution, commissioning, qualification, and operational readiness.
• Lead or advise on strategic, complex, and cross-functional projects and initiatives.
• Develop departmental engineering tools, standards, training materials, and technical guidance.

Quality, Compliance, and Risk Management

• Lead investigations into major deviations and complex technical, quality, and safety-related issues.
• Own quality records within assigned areas of expertise and ensure timely, compliant, and technically sound resolution.
• Serve as a subject-matter expert for risk management, including the identification, evaluation, mitigation, and communication of site-wide risks.
• Support Asset Life-Cycle Management assessments by evaluating equipment condition, criticality, reliability, obsolescence, and future investment needs.
• Provide technical support to Safety, Health, and Environment (SHE) teams regarding system excursions, potential regulatory or safety observations, and potential Notices of Violation (NOVs).
• Act as an audit subject-matter expert across multiple engineering, utility, HVAC, process, and manufacturing systems.
• Ensure engineering solutions and project execution comply with applicable GMP, safety, quality, regulatory, and company requirements.

Continuous Improvement and Operational Excellence

• Act as a role model for advancing Lean principles, including continuous improvement, standard work, and layered audits.
• Identify opportunities to improve system reliability, operational performance, compliance, efficiency, and cost effectiveness.
• Champion the sharing and adoption of engineering best practices across departments, functions, and sites.
• Use experience and technical insight to anticipate risks, prevent recurrence, and influence the implementation of sustainable corrective and preventive actions.

Problem Solving and Decision-Making

• Lead or participate in complex problem-solving teams involving technical, quality, safety, operational, and business challenges.
• Use extensive experience to anticipate problems and risks and develop effective mitigation and contingency strategies.
• Identify cross-functional and site-wide risks and recommend appropriate corrective actions, controls, and escalation pathways.
• Coach and mentor team members in structured problem-solving, root-cause analysis, and corrective action development.

Project and Business Execution

• Ensure projects and initiatives are delivered in accordance with approved scope, schedule, budget, quality, safety, and compliance requirements.
• Understand dependencies between strategic projects and coordinate activities to maintain progress and minimize business disruption.
• Work effectively within a matrix organization and maintain clear communication with project sponsors, stakeholders, functional leaders, and site partners.
• Support the Engineering Director with engineering zero-based budgeting, resource planning, and workload assessments.

Coaching, Training, and Leadership

• Provide direct coaching, technical guidance, and supervision to engineers, interns, contractors, and technicians as assigned.
• Set priorities, expectations, and development goals for team members and project contributors.
• Develop and deliver departmental training, technical curricula, and training materials.
• Assess and coach engineers through skills-matrix courses and technical development programs.

Stakeholder and Communication Management

• Serve as a trusted advisor to staff, management, customers, and project teams on complex technical matters.
• Build and maintain productive relationships with internal stakeholders, external partners, consultants, alliances, professional organizations, and industry networks.
• Communicate technical information, risks, gaps, decisions, and recommendations clearly across functions and organizational levels.
• Demonstrate excellent written, verbal, listening, presentation, negotiation, and influencing skills.

Required Qualifications and Experience

• Bachelor’s degree in Engineering — including Electrical, Chemical, Mechanical, Computer Engineering, or a related discipline.
• At least 10 years of experience developing, designing, commissioning, troubleshooting, and supporting industrial control systems, with significant experience developing systems from the concept phase.
• Demonstrated subject-matter expertise in clean utility systems, including WFI, pure steam, OFCA, and specialty gases.
• Demonstrated subject-matter expertise in GMP HVAC systems and cleanroom design and operation.
• Significant experience serving as a technical subject-matter expert for utilities, HVAC, process systems, and manufacturing systems on large capital projects.
• Advanced knowledge of commercial biologics manufacturing operations, including bioreactors, centrifuges, formulation, column packing, utilities, and automated manufacturing systems.
• Experience supporting regulated manufacturing environments and working in accordance with applicable GMP, quality, safety, and regulatory requirements.
• Experience leading complex technical investigations, risk assessments, corrective actions, and cross-functional improvement initiatives.
• Experience coaching, mentoring, and developing engineers and technical personnel.

Systems and Technical Tools

• Proficient computer skills, including Microsoft Office applications.
• Experience with relevant engineering, manufacturing, quality, and enterprise systems, such as SAP, TrackWise/EQV, CAD applications, document management systems, SharePoint, and regulatory systems including Angel.