Senior Project Engineer – PMO (GMP & non-GMP)

AstraZeneca • Gaithersburg, MD

2d • $122,859 - $184,289 • Onsite

About The Position

Summary of Role: The Senior Project Engineer – PMO provides advanced technical leadership and engineering governance for complex capital, infrastructure, and facility projects across AstraZeneca’s U.S. R&D network, including GMP and non-GMP environments. This role serves as the technical authority for assigned capital projects within the PMO structure, ensuring engineering excellence, regulatory compliance, lifecycle reliability, and alignment with AstraZeneca engineering standards. The Senior Project Engineer partners closely with Senior Project Managers and cross-functional stakeholders to ensure projects are technically sound, risk-mitigated, and sustainable from design through handover and operational integration. Responsibilities: Technical Leadership & Engineering Governance Serve as technical lead across project lifecycle (concept through commissioning and turnover). Evaluate infrastructure capacity, technical constraints, and constructability within active operational environments. Lead development and review of Basis of Design (BOD), technical specifications, design assumptions, and engineering standards. Ensure all engineering work align with AstraZeneca standards, applicable building codes, cGMP requirements, and SHE policies. Provide / Work with domain expertise (SME) in HVAC, critical utilities (WFI, RO, steam), process systems, electrical distribution, and/or lab infrastructure. Lead constructability reviews and value engineering assessments to optimize performance, cost, and long-term reliability. Project Delivery Support Partner with Project Managers to define technical scope, risk profile, and execution strategy. Be responsible for contractor technical performance and ensure consistency to develop intent. Provide technical guidance during installation, startup, commissioning, and qualification. Review and approve engineering submittals, RFIs, and develop changes. Contribute to project risk registers, change control documentation, and deviation investigations. Commissioning, Qualification & Turnover Develop and supervise commissioning strategies and plans to ensure systems meet safety, performance, and operational requirements. Align commissioning plans with qualification and validation requirements for GMP projects. Oversee system functional testing, documentation integrity, and turnover package completeness. Support IQ/OQ/PQ documentation and validation readiness activities. Ensure seamless handover to Facilities & Engineering Operations with full documentation and asset data integration. Digital & Asset Integration Ensure asset data integration into CMMS systems. Support development of predictive and reliability-based engineering strategies. Continuous Improvement & Standards Lead development and continuous refinement of PMO engineering standards and templates. Identify sustainability opportunities (energy, water, carbon reduction). Contribute to long-range capital planning and infrastructure master planning. GMP-Specific Responsibilities Provide senior-level technical oversight within GMP manufacturing, QC, and analytical environments. Ensure compliance with FDA, EMA, Health Canada, and internal quality standards. Support audit readiness and inspection response related to engineered systems. Lead technical investigations for deviations related to facility systems. Non-GMP-Specific Responsibilities Lead engineering efforts in research labs, vivarium, pilot plants, and administrative facilities. Drive infrastructure resilience, sustainability, and innovation initiatives. Support flexible lab design and modern workplace engineering solutions. Experience and Education Requirements: Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field). PE license strongly preferred. 8+ years of experience in pharmaceutical/biotech capital projects. Demonstrated leadership of multidisciplinary engineering teams. Strong understanding of GMP validation, commissioning, and change control processes. Experience supporting large capital programs ($5M+ preferred). Engineering Authority & Technical Depth Regulatory & Quality Compliance Risk-Based Decision Making Cross-Functional Leadership Lifecycle & Reliability Mindset Strategic Infrastructure Thinking When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field)
• 8+ years of experience in pharmaceutical/biotech capital projects
• Demonstrated leadership of multidisciplinary engineering teams
• Strong understanding of GMP validation, commissioning, and change control processes
• Experience supporting large capital programs ($5M+ preferred)
• Engineering Authority & Technical Depth
• Regulatory & Quality Compliance
• Risk-Based Decision Making
• Cross-Functional Leadership
• Lifecycle & Reliability Mindset
• Strategic Infrastructure Thinking

Nice To Haves

• PE license strongly preferred

Responsibilities

• Serve as technical lead across project lifecycle (concept through commissioning and turnover)
• Evaluate infrastructure capacity, technical constraints, and constructability within active operational environments
• Lead development and review of Basis of Design (BOD), technical specifications, design assumptions, and engineering standards
• Ensure all engineering work align with AstraZeneca standards, applicable building codes, cGMP requirements, and SHE policies
• Provide / Work with domain expertise (SME) in HVAC, critical utilities (WFI, RO, steam), process systems, electrical distribution, and/or lab infrastructure
• Lead constructability reviews and value engineering assessments to optimize performance, cost, and long-term reliability
• Partner with Project Managers to define technical scope, risk profile, and execution strategy
• Be responsible for contractor technical performance and ensure consistency to develop intent
• Provide technical guidance during installation, startup, commissioning, and qualification
• Review and approve engineering submittals, RFIs, and develop changes
• Contribute to project risk registers, change control documentation, and deviation investigations
• Develop and supervise commissioning strategies and plans to ensure systems meet safety, performance, and operational requirements
• Align commissioning plans with qualification and validation requirements for GMP projects
• Oversee system functional testing, documentation integrity, and turnover package completeness
• Support IQ/OQ/PQ documentation and validation readiness activities
• Ensure seamless handover to Facilities & Engineering Operations with full documentation and asset data integration
• Ensure asset data integration into CMMS systems
• Support development of predictive and reliability-based engineering strategies
• Lead development and continuous refinement of PMO engineering standards and templates
• Identify sustainability opportunities (energy, water, carbon reduction)
• Contribute to long-range capital planning and infrastructure master planning
• Provide senior-level technical oversight within GMP manufacturing, QC, and analytical environments
• Ensure compliance with FDA, EMA, Health Canada, and internal quality standards
• Support audit readiness and inspection response related to engineered systems
• Lead technical investigations for deviations related to facility systems
• Lead engineering efforts in research labs, vivarium, pilot plants, and administrative facilities
• Drive infrastructure resilience, sustainability, and innovation initiatives
• Support flexible lab design and modern workplace engineering solutions

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

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