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.

Key Responsibilities

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.
• Maintain and expand technical expertise through continuous learning, professional development, industry networking, and engagement with external partners and professional organizations.

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.
• Partner with Quality and Safety functions to address observations, implement improvements, and share organizational learnings.
• 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.
• Support the development of a learning organization by communicating lessons learned, best practices, and effective problem-solving approaches.

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.
• Use stakeholder networks and organizational influence to resolve problems at both the operational and strategic levels.
• Encourage creativity, collaboration, and diverse perspectives within cross-functional problem-solving teams.
• Demonstrate sound judgment, composure, and independence when managing challenges, conflicts, opportunities, and critical issues.
• 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.
• Develop engineering solutions that address business challenges and support site strategy and objectives.
• Identify and remove cross-functional obstacles that may prevent achievement of business goals.
• Define and prioritize personal and team workloads in alignment with strategic imperatives and departmental priorities.
• 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.
• Contribute to the development and delivery of departmental goals, objectives, and annual operating plans.

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.
• Establish an environment that encourages open dialogue, collaboration, inclusion, and diversity of thought.
• Promote high performance through effective communication, coaching, influence, and constructive feedback.
• Identify themes from feedback and use them to improve personal effectiveness and coach others.

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.
• Work cross-functionally to establish and improve business processes, service-level agreements, and customer-facing engineering services.
• Consistently manage stakeholders within a matrix environment through effective project and departmental forums.
• Communicate technical information, risks, gaps, decisions, and recommendations clearly across functions and organizational levels.
• Develop appropriate communication messages, techniques, and tools to address technical or capability gaps.
• Demonstrate excellent written, verbal, listening, presentation, negotiation, and influencing skills.
• Support effective communication across the engineering department and the broader site.

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.

Knowledge and Competencies

• Expert knowledge of site-wide manufacturing processes, utilities, HVAC, automated systems, equipment, and general operations.
• Strong understanding of engineering project execution, including design development, technical review, scope management, cost, schedule, commissioning, qualification, and operational handover.
• Ability to apply technical knowledge to influence departmental objectives, strategic initiatives, capital projects, and operational decisions.
• Ability to independently define priorities, manage competing demands, and deliver results with limited direction.
• Ability to understand business and site objectives and translate them into effective engineering strategies and deliverables.
• Demonstrated ability to work across multiple organizational levels and functions in a matrix environment.
• Strong risk-based decision-making, stakeholder management, facilitation, negotiation, and influencing skills.
• Broad recognition as an engineering and project management expert who consistently delivers high-quality assignments.
• Commitment to safety, quality, compliance, continuous improvement, and best-practice sharing. 

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
  • Regulatory systems, including Angel

The annual base pay for this position ranges from $146,721.60 - $220,082.40 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date