Senior Engineer

AstraZeneca • Frederick, MD

1d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Masters Degree
• 8+yrs in pharmaceutical/biotech or highly regulated manufacturing facilities engineering

Responsibilities

• 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.

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