Sr. Associate I, Quality Assurance (Quality Engineering)

Biogen - Durham, NC

Full-time - Mid Level

Durham, NC

Chemical Manufacturing

About the position

The Quality Engineering (QE) Senior Associate I is responsible for overseeing key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This role involves ensuring compliance with corporate policies, cGMPs, and safety regulations while applying knowledge of Biogen Quality Systems to coach and drive continuous improvement across functions.

Responsibilities

• Review and approve facility, utility, equipment, analytical instruments, and automation lifecycle documentation.
• Provide cGMP guidance and quality risk management support for manufacturing issues.
• Support the site changeover program by overseeing multi-product equipment inspection and release.
• Support site capital projects with GMP guidance and quality oversight.
• Lead investigations and CAPAs, driving Continuous Improvement initiatives.
• Proactively identify and resolve technical and compliance issues.
• Develop and implement aspects of various Quality Systems/System Improvements.

Requirements

• Bachelor's Degree in Engineering or related Life Science or Technical discipline with minimum 4 years of relevant industry and quality experience.
• Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and ICH guidelines.
• Experience in investigations, change controls, and CAPAs processes system knowledge.
• Demonstrated proficiency in written and verbal communication skills, including technical writing and presentations.
• Experience managing multiple, competing priorities in a fast-paced environment.
• Strong problem-solving skills and ability to develop innovative solutions.

Nice-to-haves

• Thorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments.
• Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems).
• Ability to evaluate compliance issues and interact with regulatory inspectors.
• General knowledge of Project Management competencies obtained through relevant PM training or experience.
• General knowledge of industry best practices including ISPE Baseline Guide 5, GAMP5 and ASTM E-2500.

Benefits

• Opportunities for learning and growth.
• A culture of inclusion and belonging.
• Commitment to diversity and innovation.