Maintenance Manager, Drug Substance

Introduction to role:Are you ready to lead data-driven maintenance that keeps lifesaving biologics flowing reliably to patients? This role sets the reliability agenda for upstream and downstream drug substance equipment at our Athlone site, reporting to the Associate Director of Engineering. You will own the strategy and execution that reduce unplanned downtime, elevate right-first-time performance, and ensure cGMP compliance across bioreactors, chromatography, UF/DF, single-use systems, and supporting skids.You will harness AI and advanced analytics alongside a robust CMMS to predict failures, optimize PMs, and strengthen spare-parts planning—translating insights into safe, compliant, and efficient operations. How will you blend reliability-centered maintenance with lean problem solving to unlock higher MTBF and faster MTTR? Can you inspire technicians and partners to deliver reliability improvements that protect patients, our people, and our planet?Accountabilities:

• Maintenance strategy: Implement a risk-based, reliability-centered maintenance program (preventive, predictive, condition-based) for biologics processing equipment to secure asset health and regulatory compliance.
• Performance and reliability: Improve uptime and execution using RCA, FMEA, and lean/six sigma; track MTBF, MTTR, and PM compliance to demonstrate measurable gains in availability and right-first-time performance.
• AI-enabled maintenance: Deploy AI/ML and analytics for failure prediction, PM optimization, spare-parts forecasting, spend and anomaly detection, with strong data integrity and cybersecurity controls.
• Digital systems: Manage the INFOR CMMS supporting calibrations; ensure accurate asset data, controlled changes, and effective integration with PI historian/MCS and quality systems.
• Leadership and culture: Lead and develop maintenance technicians; drive safety GEMBAs and broader SHE activities; foster cross-functional collaboration with Operations and other stakeholders to accelerate problem resolution and continuous improvement.
• Compliance and documentation: Ensure cGMP adherence, ALCOA+ data integrity, and timely closure of quality records to sustain audit readiness and robust CAPA effectiveness.
• Troubleshooting and lifecycle: Lead complex equipment troubleshooting using lean tools; plan lifecycle and obsolescence management, budgets, vendor/contractor performance, and commissioning support to maintain fitness-for-purpose over the asset life.
• Project delivery: Successfully lead teams to deliver project requirements for cost, time, and functionality, achieving all KPI targets and setting the foundation for stable operations.
• Operational handover: Work closely with site functions to ensure smooth transitions between project and operational phases, securing sustained performance and compliance.

Essential Skills/Experience:- Experience: 8–10 years in pharma/biotech maintenance/reliability (biologics preferred); 3+ years in a people leadership role.- Technical expertise: Bioreactors, chromatography, UF/DF, single-use technology, formulation vessels, autoclaves, and instrumentation/calibration.- Digital and AI skills: CMMS, calibration systems, historians, IIoT/condition monitoring; experience leading analytics or AI/ML in GxP settings.- Regulatory: Strong GMP and HPRA/FDA knowledge; familiarity with CSV/CSA and AI model governance.- Continuous improvement: Lean, six sigma, FMEA, and structured problem solving.- Leadership and communication: Team leadership, stakeholder management, and strong technical writing.- Good technical capabilities, communication skills, teamwork abilities, and initiative.- Proven ability to work well as part of a team and on own with minimum supervision.- Education: Bachelor’s degree (HETAC Level 8 or equivalent) in mechanical, electrical, mechatronics, chemical, or related engineering discipline.Desirable Skills/Experience:- Advanced degrees or professional certifications (e.g., lean/six sigma or reliability-focused credentials).- Direct experience with INFOR CMMS and integration with PI historian/MCS.- Practical experience with CSA approaches and AI/ML model lifecycle governance in regulated environments.- Demonstrated success in vendor/contractor management, commissioning support, and lifecycle/obsolescence planning.Why AstraZeneca:Join a company where bold science meets real-world impact, and where reliability excellence directly supports patients with serious and under-served conditions. You will find the energy and autonomy of a biotech combined with the scale, investment, and rigor of a global biopharma—unexpected teams in the same room unleashing bold thinking. We value kindness alongside ambition, encourage ownership beyond your lane, and equip you with modern digital tools and supportive leaders so you can build capabilities that matter and see your work translate to safer operations and medicines delivered when they are needed most.Call to Action:If you’re ready to set a new reliability benchmark in biologics and shape systems that keep critical therapies moving, bring your expertise to Athlone and move your career further, faster!

Date Posted

09-Jun-2026

Closing Date

23-Jun-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.