Maintenance Reliability Lead, RTP Bio

Job Description

About This Role:

This key leadership role within the Engineering & Facilities organization will establish and oversee the Maintenance Reliability Function, reporting to the Head of Engineering & Facilities and serving as an active participant of the E&F leadership team and the extended Site Leadership team.  This role will lead the Reliability Engineering capability development and will establish a robust ongoing practice of Reliability Engineering at the site; expectation is to continually advance the tools, analytics, and reporting to achieve and maintain an industry leadership position in asset lifecycle management.  This leader works closely with Global Engineering Systems and Compliance, Manufacturing Engineering, Facilities Engineering, and Maintenance to deploy strategies for optimizing asset reliability, availability, and maintainability. 

The Maintenance Reliability function oversees all GMP and non-GMP functional systems on site and directly influences the prevention of unplanned downtime, reduction of operating costs, and increase in productivity for all factories on site.  The major systems and business processes include but are not limited to: 

• Reliability Engineering – lead multi-disciplinary teams (including Mfg Engineering, Fac Engineering, Maintenance, and Mfg) to analyze failure modes for critical production equipment and employ reliability best practices (KPI reporting, risk assessment, preventative maintenance, spare parts strategy.)  Manage End-of-Life (EOL) and Single Point of Failure (SPOF) programs.  Actively participate in AOP to integrate replacement and refurbishment investment strategies. 
• Engineering Document Management – this team will be responsible for the administration and change control of drawings (including critical regulatory dwgs), engineering turnover packages, and for continually maintaining all GMP contents of the Meredian system in a compliant state. 
• Planning and Scheduling – this team is responsible for planning the work, identifying resources and scheduling corrective and preventative maintenance;  integrate with site master schedule; lead CMMS work order administration  
• Inventory Control – define and operationalize spare parts strategy in partnership with Reliability team; accountable to manage inventory levels for optimal availability, cost, and GMP compliance.  Leads asset induction and divestment within CMMS. 

Qualifications

Required:

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering required. 
• Advanced degree in Engineering or MBA preferred 
• A minimum of ten (10) years’ combined experience in asset lifecycle management (Engineering, Facilities, Equipment and System Commissioning, Engineering Document Management, Computerized Maintenance and Calibration Management, Reliability Program Management) in Biotech, Pharma or equivalent industry 
• A minimum of five (5) years of direct experience in an Engineering management role; Direct leadership experience in the respective Manufacturing modality (Biologics/Advance Therapy/Small Molecule/Fill Finish) and with associated GMP and non-GMP utilities 
• Advanced knowledge and application of applicable regulations including direct support / interaction with regulators in an inspection setting 
• Excellent leadership, people management, organization, communication, and inter-personal skills 
• Strong communication and conflict management skills to influence technical professionals and stakeholders, including non-specialists at all levels in the organization  
• Advanced understanding of asset lifecycle data analytic concepts and methods 
• Experience using and integrating enterprise level tools in this space to successfully execute and deliver on asset lifecycle strategies 

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.