This individual contributor who will report to the Head of Facilities Engineering Technical Authority is accountable for the development and implementation of a comprehensive reliability program that ensures the reliability, availability, and maintainability of our facilities, equipment, and systems across Biogen's global manufacturing network.
You will lead functional development, maintenance, continuous improvement, and administration of the global Reliability Engineering program (including End of Life, Single Point of Failure, etc.) including business process ownership, best practices, standards, global program/procedure change management and enforcement. You will work closely with site reliability engineers to champion requirements and benefits; and monitors overall reliability performance at enterprise level in conjunction with individual site reporting from site reliability engineers. You will also develop data-driven technical analysis and/or program recommendations from common reliability engineering KPI's such as mean time between failures, mean time to repair, overall equipment effectiveness, failure rate, availability, maintenance costs, mean time between maintenance, equipment downtime, mean time between loss, cost of unplanned downtime, etc.
This is a hybrid role to be based in RTP, NC.
Key responsibilities categorized as follows:
Program Management / Standards
Develop and implement a global reliability program that ensures the reliability, availability, and maintainability of facilities, equipment, and systems across our global network
Lead and manage the reliability program across all sites, providing guidance and support to site-level reliability teams.
Develop and implement strategies to continuously improve equipment and system reliability, reducing downtime and maintenance costs.
Develop and manage the reliability budgets, ensuring that resources are allocated effectively to achieve program goals.
Develop and maintain relationships with external vendors and industry experts to stay up-to-date on new technologies and best practices related to reliability.
Co-develop data management needed for track and trend program with CMMS BPO and System Admin
Data Analysis / Continuous Improvement
Develop and implement a data-driven approach to reliability, including the use of analytics, data visualization, and predictive maintenance tools.
Monitor and report on program performance, using key performance indicators to track progress towards program goals.
Ensure compliance with regulatory requirements, industry standards, and company policies related to reliability.
Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.
Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements.
Perform functional equivalency assessment of spare parts.
Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
Capital Planning
Collaborate with cross-functional teams to ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems.
Develop business case for improvements requiring investments and participate in capital planning for reliability related project opportunities.
Qualifications
Required:
BS in engineering (mechanical, electrical, chemical, industrial) or related facilities engineering discipline
At least 6-8 years' experience in Facilities Engineering (or related maintenance, facilities, engineering experience) in Biotech, Pharma or equivalent industry
Knowledge of Reliability Engineering / Program Management including asset lifecycle management practices; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning/qualification/validation
Knowledge and application of PDMA, FDA and EMEA regulations
Ability to influence individuals at both site and enterprise level
Strong communication and presentation skills
Strong understanding of reliability engineering analytic concepts and methods
Established network of technical leaders, peers, and stakeholders in life science industry; actively participates in industry forums, etc.
Knowledge of CMMS and engineering & maintenance business practices / procedures
Knowledge of laboratory and pharmaceutical process support equipment
Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics.
Good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
Preferred:
Knowledge of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM)
Knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable.
Membership of relevant professional / technical organization
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.
