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Form of workAbout This Role:
This Leader manages a mission critical function, Manufacturing Engineering, within Site Engineering & Facilities organization with accountability for the installation, validation and optimization of all manufacturing process equipment including cGxP warehouse technology. This is a key role on the Site E&F Leadership Team and for that reason, will frequently represent the Site E&F function in key decisions made at the Site Operations leadership team level related to Site Manufacturing strategy and direction. Frequent interaction with manufacturing, quality, and other leadership peers for coordination and decision making in assigned Manufacturing Factories. The leader will have a strong technical foundation in pharma and/or bio-pharma manufacturing technologies, operations, and CQV practices; Demonstrates the ability to effectively lead a team of engineers to optimize the reliability and performance of all assigned manufacturing systems.
What You'll Do:
- Provide leadership and supervision for a Manufacturing Engineering function to ensure ongoing reliability and performance of manufacturing process equipment. Create goals and track metrics against operational goals. Align priorities across functional subgroups in strong collaboration with all site functions, site leadership team and global functions. Develop, communicate, and implement tactical goals in support of Manufacturing operations and Facility utilization. Establish development plans for staff. Lead from a strategic and operational perspective.
- Establish procedures and programs to ensure safe, compliant, and reliable operations including Business continuity and cGMP compliance. Represent site on audits and inspections by regulatory agencies. Ensure and maintain strong safety record across department including contractors under direction.
- Develop forecasts and plans of department/business group requirements for Manufacturing Engineering function budget oversight and ensures sufficient resource allocation.
- Lead the development, execution and life-cycle management of validation activities and ensures completion of validation projects per required schedules. Ensure global procedure alignment with QMS. Present and defend validation systems to Regulatory Inspectors and outsourced partners. Provide validation information for regulatory filings and regulatory agency requests.
- Provide for 24/7 technical support for all operations, as necessary.
Required:
- Bachelor's Degree (B.S.) in an Engineering field plus a minimum of 10 years of experience in a biotechnology, pharmaceutical production environment; with in-depth knowledge on GMP validation, manufacturing operations, engineering, or facilities.
- Demonstrated experience assuming leadership roles within highly technical teams
- Large Opex/Capex budget and project experience.
- Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulations.
- Experience interfacing with FDA (or similar) investigators, authoring responses to critical, major, or minor observations and implementing corrective measures.
- Experience in coordinating / leading cross-site or cross-functional initiatives
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.
