Principal Engineer – HVAC Clean Utilities Process Frederick Maryland United States Of America

Job description

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. * 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