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Head of GMP Engineering
2 months ago
**Job Summary**
The Director of Engineering Operations will be responsible for overseeing the engineering operations at Autolus Limited, ensuring that all facilities and equipment are properly maintained, calibrated, and documented to be compliant and appropriate for use.
**Key Responsibilities**
- **Facilities Management**: Oversee all GMP engineering at Autolus Limited's manufacturing operations, ensuring that all facilities and equipment are 100% operational and maintained in support of production, QC laboratory activities, and warehousing.
- **People Management**: Manage a diverse team of maintenance and project engineering teams, as well as any onsite contractor staff, including recruitment and training requirements.
- **Regulatory Compliance**: Ensure that all facilities and equipment are compliant with cGMP and all other pertinent governmental regulations, and serve as the primary facilities contact for regulatory and partner audits.
- **Maintenance and Repair**: Lead teams that resolve and repair facility support systems safely and expeditiously, start up and shutdown facility systems, and maintain up-to-date records for all country and local requirements.
- **Vendor Management**: Work with Executive Director, Facilities, Engineering & Capital Projects to establish the GMP engineering group systems and programs, and establish optimization strategies, operational budget planning, and collaboration/support for wider engineering projects.
- **Risk Management**: Proactively manage multiple, sometimes conflicting priorities with transparency and effectiveness, while seeking creative and viable solutions to resolve conflicts.
- **Stakeholder Management**: Work alongside the Environmental Health and Safety department to ensure site processes, procedures, and risk assessments are in place and appropriate, and provide management oversight of all engineering activities and performance data through KPIs and dashboards as appropriate to senior management.
- **Regulatory Representation**: Represent Engineering and its associated activities during regulatory and statutory inspections.
**Requirements**
- 10 years' experience in managing engineering operations in a highly regulated manufacturing industry.
- Leadership experience within pharmaceutical, biologics, or cell/gene therapy industries.
- Experience with instrumentation, utilities, process engineering, maintenance, automation, computerized systems, and validation activities in a GMP environment.
- Experience managing external/3rd party vendors and contractors both remotely and in onsite operations.
- GMP experience.
**Qualifications**
- BSc/BEng in Engineering or similar or equivalent training/experience in industry.
- Master's degree or MBA.
- Green belt or Black belt in Lean Six Sigma a plus.
**Skills/Specialist Knowledge**
- Start-up culture and challenges.
- Keeps up to date with current trends in the business environment.
- Impact and influence.
- Interpersonal effectiveness.
- Leadership.
- Customer-centricity.
- Excellent interpersonal and presentation skills.
