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Maintenance Manager, Drug Substance
Job Location:
Monthly Salary:
Posted:
11 June 2026 (30+ days ago)
Posted:
Application Deadline:
8 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 planningtranslating 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 otherstakeholders 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: 810 years in pharma/biotech maintenance/reliability (biologics preferred); 3 years in a people leadership role.
- Technical expertise: Bioreactorschromatography 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: Bachelors 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 biopharmaunexpected 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 youre 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-2026Closing Date
23-Jun-2026Our 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.Required Experience:
Manager
About Company
Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders.
