Senior Engineer at AstraZeneca

Frederick, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

08 May, 26

Salary

152464.0

Posted On

07 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

HVAC Systems, Project Management, GMP Compliance, Engineering Support, Troubleshooting, Capital Projects, Collaboration, Energy Efficiency, Data Analysis, SOP Writing, Preventive Maintenance, Risk Assessment, Root Cause Analysis, Quality Standards, Change Control, FMEA

Industry

Pharmaceutical Manufacturing

Description

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, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to join the team and shape the future of AstraZeneca Operations. Accountabilities: Lead operations, troubleshooting and lifecycle management of HVAC, water pretreatment, WFI, pure steam, OFCA, clean air, specialty gases, cold rooms/freezers, boilers, hot water heating, chilled water systems, glycol systems, chillers, bio-safety cabinets, and other GMP or non-GMP systems to ensure compliance, reliability, and capacity alignment with production needs. Provide engineering project support for clean utilities and clean room qualification activities including document review, approval, and support of project execution. Deliver medium-sized capital projects from concept through execution—develop scopes, URS, budgets, schedules, risks, procurement strategies, and commissioning/qualification. Responsible for managing project lifecycle presentations and reporting to senior leadership via stage-gate reviews. Communicate project status and risk to stakeholders. Collaborate with cross functional groups and stakeholders including Manufacturing, Quality, Validation, SHE, Supply Chain, and Procurement Lead vendors/contractors to carry out projects and/or services. Responsible for supporting audits and regulatory inspections. Identify and implement energy efficiency and carbon reduction projects (e.g., heat recovery, HVAC optimization, advanced controls, utility load management, water reduction, compressed air optimization), tracking performance via KPIs and dashboards. Ensure systems meet GMP, FDA, internal quality standards, and documentation control across utilities and facilities systems. Use Siemens Insight (including PPCL), Rockwell Automation, and Emerson DeltaV to collect data, troubleshoot, perform trend analysis, optimize control sequences, and implement changes per validated procedures and change control requirements. Write and manage deviations, root cause analyses, CAPAs, Change Controls, Risk Assessments, Mitigation Actions, and EMIR/UIRs, ensuring timely closure, effectiveness verification, and robust technical documentation. Author and update SOPs, preventive maintenance procedures, calibration plans, and spare parts lists to maintain compliance, operability, and inspection readiness. Lead RCM-based programs including criticality assessments, FMEA, PdM technologies (e.g., vibration, IR, oil analysis, signals analysis), spare parts optimization, and PM strategy refinement to improve mean time between failure and reduce lifecycle cost. Essential Skills / Experience -Bachelor’s degree in Mechanical, Chemical, Electrical, or Industrial Engineering or equivalent experience. -4+ years in pharmaceutical/biotech or highly regulated manufacturing facilities engineering. Proven track record delivering capital projects up to $5M from concept through CQV in an FDA-regulated environment. Desired Skills/ Experience -Masters Degree -8+yrs in pharmaceutical/biotech or highly regulated manufacturing facilities engineering The annual base pay (or hourly rate of compensation) for this position ranges from $101,643.20 to $152,464.80 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 experience. In 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. Date Posted 07-Feb-2026 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Lead operations and lifecycle management of various systems to ensure compliance and reliability. Deliver capital projects from concept through execution while collaborating with cross-functional teams.