Role Summary
The Director, Engineering GMP/ Lab Operations is responsible for engineering operations related to Autolus’ activities, including maintenance of equipment, instrumentation and calibration, asset lifecycle management, maintenance scheduling, equipment validation, process engineering, and building management systems.
Managing a diverse team, you will collaborate closely with the Director of Facilities & Capital Projects on facilities engineering and capital projects across all sites.
Key Responsibilities
Facilities
* Oversee all GMP engineering at Autolus’ Stevenage manufacturing site.
* Manage maintenance, project engineering teams, and onsite contractors, including recruitment and training.
* Ensure all facilities and equipment are operational and maintained to support production, QC labs, and warehousing.
* Maintain GMP manufacturing facilities in compliance, properly calibrated, and well-documented for audits.
* Lead teams in resolving facility issues safely and efficiently, including startup and shutdown procedures.
* Develop and implement solutions and corrective actions for maintenance issues with proper documentation.
* Collaborate with the Executive Director on establishing systems, programs, budgets, and engineering projects.
* Ensure compliance with cGMP and regulations, maintaining accurate records.
* Coordinate vendor selection and management for equipment maintenance.
* Manage multiple priorities proactively, seeking effective solutions.
* Work with EHS to ensure safety procedures and risk assessments are in place.
* Oversee engineering activities and report performance via KPIs and dashboards.
* Represent Engineering during regulatory inspections.
* Maintain stakeholder relationships and align project goals.
Additional duties as assigned by the line manager.
Skills and Competencies
Experience
* At least 10 years managing engineering operations in a regulated manufacturing environment. (E)
* Leadership experience in pharmaceutical, biologics, or cell/gene therapy industries. (P)
* Experience with instrumentation, utilities, process engineering, automation, and validation in GMP. (E)
* Managing external vendors and contractors, both remotely and onsite. (E)
* GMP experience. (E)
Qualifications
* BSc/BEng in Engineering or equivalent. (E)
* Master’s degree or MBA preferred. (P)
* Lean Six Sigma Green/Black Belt a plus. (P)
Skills/Specialist Knowledge
* Ability to lead and motivate teams in a start-up environment with ambiguity and limited resources.
* Stay current with industry trends.
* Develop relationships and influence stakeholders at all levels.
* Resolve issues constructively and operate effectively in multicultural settings.
* Lead, attract, and inspire talent and resources.
* Focus on customer-centric decisions that enhance service quality.
* Excellent communication and presentation skills across diverse cultures and organizational levels.
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