Principal Engineer – HVAC, Clean Utilities & Process

AstraZeneca • Frederick, MD

2d • $146,722 - $220,082

About The Position

The Principal Engineer – HVAC, Clean Utilities & Process serves as a site-wide technical and subject-matter expert for GMP HVAC systems, clean utilities, manufacturing systems, and process engineering at AstraZeneca’s Frederick Manufacturing Center. The role provides technical leadership for complex capital projects, operational initiatives, quality investigations, risk management, and asset life-cycle assessments. Working independently within a matrix organization, the Principal Engineer develops and implements engineering solutions that support safe, compliant, reliable, and efficient biologics manufacturing operations. The role also coaches and develops engineers, technicians, interns, and contractors, and supports departmental objectives and continuous improvement.

The position leads or advises on strategic cross-functional projects from concept and design through execution, commissioning, qualification, and operational readiness. It provides expertise in clean utilities such as WFI, pure steam, OFCA, and specialty gases; GMP HVAC and cleanroom design and operation; and commercial biologics manufacturing processes and systems. The Principal Engineer also leads complex investigations and risk-management activities, supports audits and regulatory compliance, advances Lean and continuous-improvement practices, and communicates technical guidance and recommendations across organizational levels.

The position is based at the Frederick Manufacturing Center, a biologics manufacturing facility with more than 800 employees. The stated annual base pay range is $146,721.60–$220,082.40, with a short-term incentive bonus opportunity. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and medical, prescription drug, dental, and vision coverage. Salaried roles may be eligible to participate in the company’s equity-based long-term incentive program.

Requirements

• 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, including 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.
• 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 engineering strategies and deliverables.
• Demonstrated ability to work across organizational levels and functions in a matrix environment.
• Strong risk-based decision-making, stakeholder management, facilitation, negotiation, and influencing skills.
• Demonstrated engineering and project-management expertise and consistent delivery of high-quality assignments.
• Commitment to safety, quality, compliance, continuous improvement, and sharing best practices.
• 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.

Responsibilities

• Serve as the site-wide technical expert for HVAC, clean utilities, process systems, and related manufacturing systems, including buildings, internal systems, and external infrastructure.
• Provide expertise in clean utility systems, including Water for Injection (WFI), pure steam, OFCA, and specialty gases.
• Provide expertise in GMP HVAC systems, cleanroom design and operation, environmental control, and related compliance requirements.
• Apply advanced knowledge of commercial biologics manufacturing operations, including bioreactors, centrifuges, formulation, column packing, utilities, automated systems, equipment, and site operations.
• Represent engineering on large capital projects from concept and design 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 continued learning and engagement with external partners and professional organizations.
• Lead investigations into major deviations and complex technical, quality, and safety issues; own quality records in assigned areas and ensure timely, compliant, technically sound resolution.
• Serve as a subject-matter expert in risk management and support identification, evaluation, mitigation, and communication of site-wide risks.
• Support asset life-cycle assessments by evaluating equipment condition, criticality, reliability, obsolescence, and future investment needs.
• Provide technical support to Safety, Health, and Environment teams regarding system excursions and potential regulatory or safety observations and Notices of Violation.
• Act as an audit subject-matter expert across engineering, utility, HVAC, process, and manufacturing systems; partner with Quality and Safety to address observations and implement improvements.
• Ensure engineering solutions and project execution comply with applicable GMP, safety, quality, regulatory, and company requirements.
• Promote Lean principles, continuous improvement, standard work, and layered audits; identify opportunities to improve reliability, performance, compliance, efficiency, and cost effectiveness.
• Share engineering best practices and lessons learned across departments, functions, and sites; anticipate risks and support sustainable corrective and preventive actions.
• Lead or participate in complex problem-solving teams; develop risk mitigations and contingency strategies, recommend corrective actions and controls, and coach team members in root-cause analysis and corrective action development.
• Ensure projects and initiatives meet approved scope, schedule, budget, quality, safety, and compliance requirements; coordinate dependencies and remove cross-functional obstacles.
• Develop engineering solutions supporting business challenges and site strategy; prioritize workloads and communicate with project sponsors, stakeholders, functional leaders, and site partners.
• Support the Engineering Director with zero-based budgeting, resource planning, and workload assessments; contribute to departmental goals, objectives, and annual operating plans.
• Coach, guide, and supervise engineers, interns, contractors, and technicians as assigned; set priorities, expectations, and development goals.
• Develop and deliver departmental training and technical curricula, and assess and coach engineers through skills-matrix courses and technical development programs.
• Foster open dialogue, collaboration, inclusion, and diversity of thought; promote performance through communication, coaching, influence, and constructive feedback.
• Advise staff, management, customers, and project teams on complex technical matters; build productive relationships with internal stakeholders and external partners.
• Work cross-functionally to establish and improve business processes, service-level agreements, and customer-facing engineering services.
• Communicate technical information, risks, gaps, decisions, and recommendations clearly across functions and organizational levels; support communication across the engineering department and site.

Benefits

• Qualified retirement program (401(k) plan)
• Paid vacation
• Paid holidays
• Paid leaves
• Medical coverage
• Prescription drug coverage
• Dental coverage
• Vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in the equity-based long-term incentive program for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Principal