Director, Engineering GMP/Lab Operations
3 months ago
Role Summary
The Director, Engineering GMP/ Lab Operations is responsible for engineering operations relating to Autolus’ operations including, but not limited to, maintenance of equipment, instrumentation and calibration, asset life cycle management, Maintenance scheduling, equipment validation, process engineering and building management engineering / systems.
Managing a diverse team, you will work closely with the Director, Facilities & Capital Projects in relation to any facilities engineering or capital project activities across all our sites.
Key Responsibilities
Facilities
- Oversight of all GMP engineering at Autolus’ Stevenage manufacturing operations.
- People management of maintenance and project engineering teams as well as any onsite contractor staff . This will include recruitment & training requirements.
- Ensure that all facilities and equipment are 100% operational and maintained in support for production, QC laboratory activities, and warehousing across all sites.
- Ensures our cGMP manufacturing facilities are properly maintained, calibrated, and documented to be compliant and appropriate for use. Serves as primary facilities contact for regulatory and partner audits.
- Lead teams that resolve and repair facility support systems safely and expeditiously, start up and shutdown facility systems, maintain up to date records for all country and local requirements.
- Recommend solutions and implements appropriate corrective actions for major or complex maintenance issues using good documentation practices
- 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.
- Ensuring compliance with cGMP and all other pertinent governmental regulations in the execution of and record keeping for all maintenance and calibration activities on the site.
- In collaboration with the relevant site customer(s) and Strategic Sourcing and Procurement, drive vendor selection, management, and resource optimization for equipment maintenance and servicing.
- Proactively manages multiple, sometimes conflicting priorities with transparency and effectiveness, while seeking creative and viable solutions to resolve conflicts.
- Works alongside the Environmental Health and Safety department to ensure site processes, procedures and risk assessments are in place and appropriate.
- Provide management oversight of all engineering activities and provide performance data through KPIs and dashboards as appropriate to senior management.
- Represent Engineering and its associated activities during regulatory & statutory inspections.
- Ensure effective stakeholder management by maintaining clear communication, fostering relationships, and aligning project goals with stakeholder expectations.
To perform other duties which are directed by the line manager.
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
- 10 years’ experience in managing engineering operations a highly regulated manufacturing industry. (E)
- Leadership experience within pharmaceutical, biologics or cell/gene therapy industries. (P)
- Experience with instrumentation, utilities, process engineering, maintenance, automation, computerized systems and validation activities in a GMP environment. (E)
- Experience managing external / 3 rd party vendors & contractors both remotely and in onsite operations. (E)
- GMP Experience (E)
Qualifications
- BSc / BEng in Engineering or similar or equivalent training / experience in industry. (E)
- Master’s degree or MBA (P)
- Green belt or Black belt in Lean Six Sigma a plus. (P)
Skills/Specialist knowledge
- Start-up Culture and Challenges – Demonstrated ability to lead and motivate a team in the face of the ambiguity, lean resources, and multitasking requirements as in a start-up environment. Demonstrated ability to teach, work hands on when needed, and to lead by example from the front.
- Keeps up to date with current trends in the business environment.
- Impact and influence — Develops and maintains effective relationships (both internal and external) to facilitate changes necessary. Able to influence both above, to peers and below in a matrix environment.
- Interpersonal effectiveness — Understand different points of view and resolves issues in a constructive manner. Able to operate effectively and comfortably in an international multicultural working environment.
- Leadership — Ability to attract, lead, manage and inspire talent and resources across the entire organization.
- Customer-centricity — Considers the impacts of all decisions on the customer, ensuring that any changes will improve and not impede customer service.
- Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.
-
Director of Engineering Operations
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Director, Engineering GMP/Lab OperationsAt Autolus Limited, we are seeking a highly skilled and experienced Director, Engineering GMP/Lab Operations to join our team. This is a critical role that will be responsible for leading our engineering operations, ensuring compliance with GMP regulations, and driving process improvements.Key...
-
Director of Engineering Operations
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Director, Engineering GMP/Lab OperationsAt Autolus Limited, we are seeking a highly skilled and experienced Director, Engineering GMP/Lab Operations to join our team. This is a critical role that will be responsible for leading our engineering operations, ensuring compliance with GMP regulations, and driving process improvements.Key...
-
Director of Engineering Operations
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Director, Engineering GMP/Lab OperationsAt Autolus Limited, we are seeking a highly skilled and experienced Director, Engineering GMP/Lab Operations to join our team. This is a critical role that will be responsible for leading our engineering operations, ensuring compliance with GMP regulations, and driving process improvements.Key...
-
Director of Engineering Operations
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Director, Engineering GMP/Lab OperationsAt Autolus Limited, we are seeking a highly skilled and experienced Director, Engineering GMP/Lab Operations to join our team. This is a critical role that will be responsible for leading our engineering operations, ensuring compliance with GMP regulations, and driving process improvements.Key...
-
Director of Engineering Operations
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Ltd Full timeJob Title: Director, Engineering GMP/Lab OperationsThe Director, Engineering GMP/Lab Operations is a key leadership role responsible for overseeing engineering operations at Autolus Ltd's manufacturing sites. This includes managing a diverse team of maintenance and project engineers, as well as external contractors, to ensure seamless operations and...
-
Director of Engineering Operations
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Ltd Full timeJob Title: Director, Engineering GMP/Lab OperationsThe Director, Engineering GMP/Lab Operations is a key leadership role responsible for overseeing engineering operations at Autolus Ltd's manufacturing sites. This includes managing a diverse team of maintenance and project engineers, as well as external contractors, to ensure seamless operations and...
-
Director of Engineering Operations
1 week ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Director, Engineering GMP/Lab OperationsAutolus Limited is seeking a highly experienced and skilled Director, Engineering GMP/Lab Operations to lead our engineering operations in a highly regulated manufacturing industry.Key Responsibilities:Oversight of all GMP engineering at Autolus' Stevenage manufacturing operations.People management of...
-
Engineering Lead for GMP Operations
2 months ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeRole Summary Autolus Limited is seeking a highly motivated and experienced Engineering Lead to oversee all aspects of engineering operations within our GMP manufacturing facilities. This role will play a crucial part in ensuring the smooth and efficient operation of our production, quality control (QC) laboratory activities, and warehousing across all...
-
Engineering Lead for GMP Operations
2 months ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeRole Summary Autolus Limited is seeking a highly motivated and experienced Engineering Lead to oversee all aspects of engineering operations within our GMP manufacturing facilities. This role will play a crucial part in ensuring the smooth and efficient operation of our production, quality control (QC) laboratory activities, and warehousing across all...
-
Engineering Director
1 month ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Engineering BusinessThe Director, Engineering GMP/Lab Operations is responsible for overseeing engineering operations at Autolus' Stevenage manufacturing site. This includes maintenance of equipment, instrumentation, and calibration, as well as asset life cycle management, maintenance scheduling, equipment validation, process engineering, and...
-
Engineering Director
1 month ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Engineering BusinessThe Director, Engineering GMP/Lab Operations is responsible for overseeing engineering operations at Autolus' Stevenage manufacturing site. This includes maintenance of equipment, instrumentation, and calibration, as well as asset life cycle management, maintenance scheduling, equipment validation, process engineering, and...
-
Head of GMP Engineering
2 months ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Description**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...
-
Head of GMP Engineering
2 months ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Description**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...
-
Director of Engineering Operations
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Ltd Full timeJob Title: Director of Engineering OperationsThe Director of Engineering Operations will be responsible for overseeing the engineering operations at Autolus Ltd, ensuring that all facilities and equipment are properly maintained, calibrated, and documented to meet regulatory requirements. This role will also involve managing a diverse team of engineers and...
-
Director of Engineering Operations
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Ltd Full timeJob Title: Director of Engineering OperationsThe Director of Engineering Operations will be responsible for overseeing the engineering operations at Autolus Ltd, ensuring that all facilities and equipment are properly maintained, calibrated, and documented to meet regulatory requirements. This role will also involve managing a diverse team of engineers and...
-
Director of Engineering Operations
5 days ago
Stevenage, Hertfordshire, United Kingdom Autolus Ltd Full timeThe Director of Engineering Operations will oversee engineering operations at Autolus' manufacturing sites, ensuring 100% operational and maintained facilities and equipment. This includes managing a diverse team, working closely with the Director of Facilities & Capital Projects, and overseeing GMP engineering at the Stevenage manufacturing operations.Key...
-
Senior Engineering Operations Manager
1 week ago
Stevenage, Hertfordshire, United Kingdom https:www.energyjobline.comsitemap Full timeJob SummaryThe Director, Engineering GMP/Lab Operations is responsible for overseeing engineering operations at Autolus' manufacturing sites. This includes maintenance of equipment, instrumentation, and calibration, as well as asset life cycle management, maintenance scheduling, equipment validation, process engineering, and building management...
-
Engineering Director
1 month ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Engineering DirectorThe Engineering Director will be responsible for leading the engineering operations at Autolus' Stevenage manufacturing site. This includes overseeing all GMP engineering activities, managing a diverse team of maintenance and project engineers, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead the...
-
Engineering Director
1 month ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Engineering DirectorThe Engineering Director will be responsible for leading the engineering operations at Autolus' Stevenage manufacturing site. This includes overseeing all GMP engineering activities, managing a diverse team of maintenance and project engineers, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead the...
-
Engineering Director
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Autolus Limited Full timeJob Title: Engineering DirectorThe Engineering Director will be responsible for leading the engineering operations at Autolus' Stevenage manufacturing site. This includes overseeing all GMP engineering activities, managing a diverse team of maintenance and project engineers, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead the...
