Sr. Associate I, Quality Engineering

About the Role

Quality Engineering Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen RTP facility. The role requires adherence to site and corporate policies, cGMPs, safety, environmental, and human resources policies, and procedures. The candidate will apply Biogen Quality Systems knowledge in coaching and driving continuous improvement for all Quality Systems across functions.

The QE Senior Associate I will provide quality oversight of Engineering, Manufacturing, Maintenance and Facilities teams to ensure compliance with Biogen and industry cGMP standards. The role may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance, and support the Manager in interviewing and training activities, providing feedback for personnel development, and making timely decisions related to systems, maintenance, or facility events.

What You'll Do

• Review and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews
• Review and approval of changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, material / components, and business processes associated with IT GMP computerized systems
• Provide cGMP guidance and quality risk management support of manufacturing on-the-floor issues with equipment or systems, including review and approval of deviations and CAPAs
• Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release
• Support site capital projects by providing GMP guidance, risk management input and quality oversight during shutdown planning, release and other major equipment / facility improvements
• Review and approval of GMP Preventive / Corrective maintenance work as applicable
• Lead investigations and CAPAs including driving Continuous Improvement initiatives
• Proactive identification and resolution of technical and compliance issues / gaps
• Develop and implement aspects of various Quality Systems / System Improvements
• Other duties as assigned

Who You Are

You are a motivated QA expert with strong Drug Manufacturing / Engineering experience, adaptable to changing priorities. You are detail-oriented, a strong critical thinker, and able to work across multiple organizational levels. You are a team player, with high personal accountability and the ability to hold peers and stakeholders accountable to commitments.

Required Skills

Preferred Skills

Additional Information

The base compensation range for this role is : $79,000.00-$103,000.00

Base salary is determined through an analytical approach using a combination of factors including relevant skills & experience, job location, and internal equity. Regular employees are eligible for both short-term and long-term incentives, including cash bonus and equity opportunities, based on individual, business unit, and company performance.

Biogen offers a full and competitive range of benefits to support employees and their families, including Medical, Dental, Vision, Life insurances; Wellness programs; Short- and Long-Term Disability insurance; paid vacation and year-end shutdown; 12 company holidays plus up to 3 Personal Significance days; 80 hours of sick time per year; Maternity and Parental Leave; 401(k) with company match; Employee stock purchase plan; Tuition reimbursement up to $10,000 per year; and Employee Resource Groups.

Why Biogen?

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide stability and resources while supporting individual contributions. Our team offers opportunities for learning, growth, and expanding skills as we work to deliver life-changing medicines. Caring Deeply. Achieving Excellence. Changing Lives.

Biogen is an equal opportunity employer. We are committed to building a diverse and inclusive environment. 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 protected status. Biogen is an E-Verify Employer in the United States.

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