Job Description
About This Role
The Sr. Specialist I, Instrumentation& Controls (I&C) position supports the daily activities of the I&C technicians and management at the 5000 Davis Drive Drug Substance site. The site includes laboratory facilities, central utilities, warehouse, drug substance manufacturing, and support buildings and equipment. The position will support calibration and maintenance strategies for site instrumentation and control systems in full compliance with Quality, Safety and cGMP standards and ensure the highest level of customer satisfaction. In this role you will provide technical subject matter (SME) expertise for the I&C group, assist in I&C technical management in a leadership role. This includes managing CMMS workflows for instrumentation, outsourced vendors, and Unity contractor management, completing investigation and change control documentation, and closure through Trackwise and PLM systems. Reviewing / approving / closing work performed by technician staff in the Computerized Maintenance Management System (CMMS). Supports the reliability engineering and continuous improvement initiatives.
What You'll Do
- Support I&C daily activities / provide direction and technical guidance for the team.
- Provide vendor/Unity management support including onboarding and training of contractors for the team.
- Recommend and implement changes to CMMS system and related procedures to improve compliance, reliability, optimize technician time, reduce equipment down time and provide timely closure of work orders.
- Assist with Trackwise(TRN/CAPA) and PLM(GCC) workflows and closure.
- Provide audit documentation/SME support for the team.
- Hold daily I&C ITW team huddles.
- Assist in I&C Team Management in a leadership role as needed.
Who You Are
You are motivated and task driven with good leadership and communication skills. You can work with cross functional maintenance, engineering, manufacturing, and Quality groups
Qualifications
- Associate degree with an emphasis in Instrumentation/electronics plus a minimum of 3 years related industry experience or a high school diploma (or equivalent) plus a minimum of 5 years related industry/military experience and/or training, or an equivalent combination of education and experience.
- Experience in the biotechnology, pharmaceutical or other regulated health care industries.
- In-depth knowledge of Manufacturing operations in a Biopharma environment required.
- Proven leadership skills with the ability to motivate and develop a technical team.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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.