Job Description
The Head of Global Engineering is responsible for providing leadership and oversight to the global and site (internal and external) based Engineering functions. Functional responsibility includes the disciplines of Process Engineering, Process Automation, Equipment and System Validation, and Capital Project execution. All functions serve the clinical and commercial manufacturing operations both internally and externally across multiple modalities. Responsible for strategic development, engineering requirements for new modalities, specifically ASO expansion and Gene Therapy engineering activities including external manufacturing and future internal manufacturing build. This position is responsible for the corporate functions of Engineering for Capital Planning, Engineering studies, External Manufacturing, and Engineering standards. Manages overall PO&T capital budget of ~$150-200M annually and operating expense budget of ~$10M annually.
Want more jobs like this?
Get Software Engineer jobs in Research Triangle Park, NC delivered to your inbox every week.
Principal Accountabilities:
• Directs Engineering functional departments in support of Manufacturing operations and Capital Project planning and execution. Creates goals and tracks metrics against operational goals. Aligns priorities across functional groups and sites as a member of the GMTO Leadership Team. Develops, communicates, and implements strategic goals in support of Global Manufacturing & Engineering operations. Ultimately responsible for all engineering related goals, initiatives required to meet PO&T objectives.
• Forecasts and accountable for a multi-department budget for both Operational Expense and Capital Expense. Ensures each Engineering sub-function maintains budget and contracts to meet financial and performance targets. Maintain facility asset valued in excess of $2 billion in a reliable and cGMP validated compliant state. Responsible for the PO&T capital planning and reporting. Develops and maintains capital project guidelines and governance.
• Aligns strategic initiatives and goals across PO&T and resources Engineering to successfully implement against aggressive targets. Assure consistent implementation and use of standards, policies, and methods for the execution of Engineering activities.
Responsible to develop people and leaders within the organization. Creates succession plans and conducts talent reviews across the various Engineering disciplines. Maintains and creates effective organizations to support global and site operations. Ensures talent development and progression within the function.
#LI-CL1
Qualifications
Education
- This position requires a minimum of a bachelor's degree in Engineering or related degree with Engineering experience (Mechanical, Electrical, Civil, Industrial or Chemical preferred).
Required Skills
- A minimum of fifteen (15) years’ experience in Engineering in the Biotech or related industry including ten (10) years of supervisory/management experience. Knowledge of related manufacturing and utilities systems and current pharmaceutical practices is essential. Excellent leadership, project management, organizational, communication, and inter-personal skills are required.
- Critical Knowledge of Process Equipment, Distributed Control Systems, Equipment/System Validation, Facility Operations, Instrumentation, cGMP regulations, and Biotech Manufacturing Unit Operations.
- Experience with biologics drug substance manufacturing, drug product formulation and filling operations, cGMP utilities, and utility generation.
- Demonstrate ability to independently influence and/or manage multiple projects simultaneously.
- Demonstrate strong organizational skills and multiple project and time/resource management skills.
- Demonstrate strong leadership capability with excellent strategic vision and conceptual skills.
- Ability to serve as a consultant to all levels of management.
- Demonstrate excellent verbal and written communication.
- Demonstrate excellent interpersonal skills including the ability to resolve problems with poise, tact and diplomacy.
- Ability to interact with people of a wide variety of backgrounds, levels of responsibility, and education levels.
- Ability to maintain confidentiality.
Additional Information
All your information will be kept confidential according to EEO guidelines.