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Building exceptional teams to revolutionize Car T-cell Therapies in Stevenage and beyond
Autolus is seeking an experienced Director, Engineering to lead our engineering operations within GMP and lab environments. This critical role involves overseeing equipment, instrumentation, calibration, asset lifecycle management, and facilities engineering systems, ensuring all systems are compliant and fully operational.
Key Responsibilities:
1. Lead GMP engineering operations at Autolus’ Stevenage manufacturing site.
2. Manage and develop maintenance, project engineering teams, and onsite contractors (recruitment, training, etc.).
3. Ensure that all facilities, equipment, and systems are operational and compliant to support production, QC labs, and warehousing.
4. Serve as the primary point of contact for regulatory and partner audits.
5. Recommend and implement corrective actions for maintenance and complex engineering issues.
6. Collaborate with the Executive Director to establish engineering systems, programs, optimization strategies, and budgets.
7. Ensure compliance with cGMP, governmental regulations, and appropriate documentation for all maintenance and calibration activities.
8. Drive vendor selection, management, and resource optimization for equipment maintenance and servicing.
9. Oversee engineering activities, providing performance data and KPIs to senior management.
10. Represent the engineering department during regulatory and statutory inspections.
11. Collaborate with Environmental Health and Safety to ensure proper site processes and risk assessments are in place.
Key Qualifications & Experience:
1. 10+ years of experience in managing engineering operations in a highly regulated manufacturing environment.
2. Leadership experience within the pharmaceutical, biologics, or cell/gene therapy industries.
3. Extensive experience with instrumentation, utilities, process engineering, maintenance, and validation in GMP environments.
4. Experience managing external vendors and contractors.
5. GMP experience is a must.
6. BSc/BEng in Engineering or related field (equivalent experience/training acceptable).
7. Master’s degree or MBA (preferred).
8. Lean Six Sigma Green or Black Belt (preferred).
Key Skills:
1. Proven ability to lead and motivate teams in fast-paced, startup environments.
2. Strong interpersonal and leadership skills, capable of influencing across all organizational levels.
3. Ability to maintain effective relationships with internal and external stakeholders.
4. Excellent communication and presentation skills.
If you are ready to lead in a growing, dynamic organization and shape the future of cellular therapies, we encourage you to apply!
Seniority level
Director
Employment type
Full-time
Job function
Science and Engineering
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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