Sr Associate I, Quality Engineering (Pharma Site)

Job Description

About this Position

The Sr. Associate I of Quality Engineering will ensure that Quality systems supporting facility, equipment, automation, and utilities remain in compliance with Biogen and industry cGMP standards. Additionally, the Sr. Associate I will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. The Sr. Associate I in Quality Engineering (QE) is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.

What You’ll Do:

• Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, instrument & controls oversight, and identify gaps in existing Quality systems and propose solutions to site management.
• Assist in the development and implementation of Global Quality Systems, leading site and global initiatives, provides oversight with respect to the proper administration and adherence to all Biogen policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the utilities, equipment, and RTP site.
• Perform review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. Facility and equipment controls and release during shutdown, construction, product changeover.
• Provide cGMP guidance and quality support of Manufacturing on the floor issues, including assistance with deviation initiation.
• Review of PM work orders and CM work orders as applicable to cGMP systems. Proactive identification and resolution of both technical and compliance issues/gaps.
• Develop and implement aspects of various Quality Systems/System Improvements.
• Performs QA review of alarm assessments for cGMP equipment.
• The Sr. Associate I QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. In addition, support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies.

Who You Are

You are agile and thrive in executing quality work in a fast-paced environment. You are quality minded and patient centric: you know delivering quality work helps deliver lifesaving therapies to our communities.

Qualifications

Bachelor’s Degree in Engineering or related Life Science or Technical discipline
5 years of Quality-related experience in the following disciplines:
• GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems.
• Robust experience with Change Control program management.
• Knowledge of FDA/EMEA regulations and compliance.
• Robust knowledge of current global Regulatory Quality requirements.
• Regulatory Agency inspection experience.

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.