Project Engineer – PMO (GMP & non-GMP)

Summary of Role:

The Project Engineer – PMO provides advanced technical leadership and engineering governance for capital, infrastructure, and facility projects across AstraZeneca’s U.S. R&D network, including GMP and non-GMP environments. This role serves as strong technical support within the PMO structure, ensuring engineering excellence, regulatory compliance, lifecycle reliability, and alignment with AstraZeneca engineering standards. The Project Engineer partners closely with Project Managers and multi-functional partners to ensure projects are technically sound, risk-mitigated, and balanced from build 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 you're doing 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 oversight during installation, startup, commissioning, and qualification. 

• Review and approve engineering submittals, RFIs, and design changes. 

• Contribute to project risk registers, change control documentation, and deviation investigations. 

Commissioning, Qualification & Turnover 

• Develop and oversee 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. 

• Leverage digital tools and asset data to improve lifecycle performance and reliability outcomes. 

• 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:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field). 

• PE license strongly preferred. 

• 4+ years of experience in pharmaceutical/biotech capital projects. 

• Demonstrated leadership of multidisciplinary engineering teams. 

• Strong understanding of GMP validation, commissioning, and cha