Project Engineer – PMO (GMP & non-GMP)
Gaithersburg, MD - USA
Job Summary
Summary of Role:
TheProject Engineer PMO provides advanced technical leadership and engineering governance for capital infrastructure and facility projects across AstraZenecas U.S. R&D network including GMP and non-GMP role serves as strong technical support within the PMO structure ensuring engineering excellence regulatory compliance lifecycle reliability and alignment with AstraZeneca engineering 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 youre doingalign withAstraZeneca 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 tooptimizeperformance cost and long-term reliability.
Project Delivery Support
Partner with Project Managers to define technical scope risk profile and execution strategy.
Be responsible forcontractortechnical performance and ensure consistency to develop intent.
Provide technical oversight during installation startup commissioning andqualification.
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 andvalidationreadiness 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.
Identifysustainability opportunities (energy water carbonreduction).
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:
Bachelors degree in Engineering(Mechanical Electrical Chemical or related field).
PE licensestronglypreferred.
4 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 ($1M 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base pay for this position ranges from $86816 to $133224. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Why AstraZeneca:
Here you will help turn a rich complex pipeline into real treatments by uniting science disciplined execution and smart digital tools. You will collaborate with unexpected teams that challenge ideas and accelerate progress learning alongside peers who value kindness as much as ambition. With investment in cutting-edge capabilities and a clear focus on speed quality and sustainability your leadership will shorten the path from study start-up to submission and ultimately to patients who need our medicines.
Call to Action:
Step forward to lead the clinical programs that shape the next wave of medicinessend your CV today and help us deliver impact at speed!
Date Posted
01-Apr-2026Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
IC
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more