Ensure potential safety hazards are identified/shared and effective corrective actions are rapidly implemented.
• Daily management of the bRT Site Engineering teams, including Process Engineering, Process Automation, and Equipment Commissioning, Qualification and Validation.
• In close partnership with the Site Facilities team, make the process equipment work for our unique gene therapy processes
• Provide strategic leadership and own the overall process for equipment selection (including generation of user required specifications and design of custom equipment), automation, start-up (FAT/SAT), qualification/commissioning, change management, technical support, development and maintenance of equipment drawings, quality events (change controls and deviations), and project documents for the company’s expanding Durham facilities
• Oversee equipment from conception to decommissioning
• Oversees the functioning of all process related Engineering systems
• Establish site good engineering practices (user required specifications, engineering/design specifications, naming/tagging procedures, project-to-owner turnover procedures, engineering documentation and changes, etc.)
• Support Facilities/Maintenance with development of a spare parts, calibration and preventive maintenance program.
• Develop the process engineering team to support the equipment for both clinical and commercial manufacturing, and future capital projects
• Develop systems for managing and executing equipment related capital projects for the site.
• Monitors budgets and approves contracts
• Responsible for developing budgets and long-range process related plans for Engineering, Automation, and Equipment Commissioning/Qualification/Validation based on company growth and future needs
• Provide strategic leadership and ownership of automation standards, system design and integration, including hardware/software design specification development, user/functional requirement development, integration and validation. Develop a long-term vision for the site automation platform and drive improvements for the existing system.
• In collaboration with Quality Assurance, provide strategic leadership and ownership of authoring regulatory documents, own facility and equipment validation and execute requalification program
• In partnership with global Facilities, own and drive the site master plan
• Develop and approve documents related to site management; SOP’s, Work Plans, Job Aids, Various Policies and Procedures, etc.
• Oversees contractors supporting Engineering, Automation, equipment commissioning, qualification, and validation related projects
• Collaboration with external engineering firms and the cross-functional bluebird team, including EHS, Manufacturing, Manufacturing Sciences & Technology, Facilities, OE/Project Management, Quality Assurance, Quality Control, IT, People Partners, Finance and Site Leadership to deliver results
• Support cross-functional strategy development and implementation as part of the site leadership team
BS/MS in Engineering or related field
Minimum of 5 years of experience in or leading an Engineering function
Minimum of 10 years of pharmaceutical/biotech manufacturing industry or related experience is required
Minimum of 15 years of managerial experience is required Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections is required.
Prior cGMP cell or gene therapy manufacturing experience is highly desired
Strong knowledge of process equipment, process automation, equipment commissioning, equipment qualification, and equipment validation is required
Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc. is required
Experience in the operations and management of Engineering, Automation, commissioning, qualification and equipment validation systems in a GMP environment
Experience in Engineering construction projects
Significant project management skills in all areas of Engineering management
Knowledge of OSHA guidelines, and other federal, state and local regulations is required
Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself