Manufacturing Specialist II, MFG Tech Ops
Biogen
This position is on-site and follows a M-F business hours schedule
About This Role
The Manufacturing Specialist II plays a key role in authoring and managing manufacturing technical instructions and batch records. Operating with full procedural proficiency, this role supports unit operations and executes projects tied to Quality Management System (QMS) commitments such as CAPAs, deviations, and change controls. The specialist collaborates cross-functionally to support technology transfers, troubleshoot operational issues, and drive continuous improvement initiatives—all while maintaining compliance and safety standards.
What You’ll Do
Act as Subject Matter Expert (SME) on manufacturing equipment and processes within defined scope
Author technical instructions and records including MPRs, SLRs, SOPs, work instructions, and forms
Support technology transfer activities and communicate needs across teams
Initiate and manage manufacturing-focused Change Controls, CAPAs, and Planned Exceptions
Provide technical solutions to resolve operational issues based on existing procedures
Lead or contribute to projects as part of cross-functional teams
Identify and implement continuous improvement opportunities across manufacturing operations
Who You Are
A detail-oriented and proactive manufacturing professional with strong technical writing skills, cross-functional collaboration experience, and a passion for process optimization. You thrive in a fast-paced environment and are comfortable navigating both routine and complex manufacturing scenarios.
Required Skills
Bachelor’s degree in Life Sciences or Engineering OR Associate's Degree plus 2 years of relevant experience OR High School Diploma plus 4 years of relevant experience
Familiarity with GMP, regulatory requirements, and cleanroom operations
Computer based skills, including MS Office (Word, Excel)
Proficiency in authoring manufacturing documentation and interpreting technical procedures
Experience with QMS elements such as CAPAs and change controls
Ability to troubleshoot and resolve technical issues independently
Effective communicator across cross-functional teams
Preferred Skills
Experience supporting technology transfer and continuous improvement initiatives
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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.