Principal Engineer – HVAC, Clean Utilities & Process

Principal Engineer – HVAC, Clean Utilities & Process Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, plays a direct role in treating patients with cancer, respiratory diseases, and autoimmune conditions globally.

At FMC, we are committed to delivering life-changing medicines while also creating a workplace where people feel valued and connected. From catered site events and friendly competitions to community outreach, environmental and wellness programs, and team-building activities, we make time to celebrate achievements and recognize the diversity of our workforce. We are dedicated to fostering a culture of inclusion, collaboration, and continuous learning through ongoing skill development and training opportunities for our employees.

Driven by our ambition to accelerate growth, improve patients’ lives, and shape the future of AstraZeneca Operations, there has never been a more exciting time to join our team.

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.

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