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Manufacturing Process Specialist
About this Role
In this Parenteral Filling Manufacturing Process Specialist role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.
What You’ll Do
- Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records
- management and project execution –participate in projects (simple to moderately complex in nature), facilitating timely execution.
- Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
- Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
- Initiate, own, and manage manufacturing focused change controls, CAPAs, investigations, and planned exceptions
- This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.
Who You Are:
If you are a highly detailed and focused individual who demonstrates a moderate level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.
Qualifications
Required Skills:
- Bachelor’s degree (Life Sciences or Engineering ) preferred, with 0-1 years of transferrable experience
- Associates Degree or Bioworks Certificate and 2 years of transferrable Experience
- High School Diploma (or Equivalent) 4 years of transferrable experience
Preferred Skills:
- Prior experience supporting Investigations within manufacturing operations
- Prior experience in manufacturing – drug product operations
- Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
- Robust understanding of quality and cGMP principles
- Fundamental knowledge of change control in cGMP environment
- Intermediate to advanced skills in Microsoft Office and computer-based quality systems
- Intermediate to advanced level of technical writing skill
- Ability to interpret manufacturing process design documentation
- Excellent oral and written communication skills
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.
