Manufacturing Specialist III

1 week ago

Triangle Township, United States Biogen Full time
Job Title: Manufacturing Specialist III

Biogen is seeking a highly skilled Manufacturing Specialist III to join our team. As a key member of our Manufacturing Technical Operations Team, you will be responsible for manufacturing support tasks, including technical writing, project management, and process implementation.

Key Responsibilities:
  • Author manufacturing documentation, including procedures, work instructions, and changeover protocols.
  • Project management and project execution, leading or participating in projects to ensure timely execution.
  • Utilize technical experience and judgment to identify, troubleshoot, and resolve technical and operational problems.
  • Proactively identify continuous improvement opportunities and drive site implementation.
  • Partner with cross-functional groups to identify and drive implementation of continuous improvement opportunities.
  • 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, and planned exceptions.
Requirements:
  • Bachelor's degree in Life Sciences or Engineering, preferred, with 3 years of transferrable experience.
  • Associates Degree or Bioworks Certificate and 5 years of transferrable experience.
  • High School Diploma (or Equivalent) with 7 years of transferrable experience.
Preferred Skills:
  • Prior experience in manufacturing, particularly in drug substance biologics, downstream or upstream 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 a 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.
About Biogen:

We are a global team committed 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.

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.

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.

  • Manufacturing Process Maintenance Specialist III

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job Title: Manufacturing Process Maintenance Specialist IIIAbout the CompanyBiogen is a leading biotechnology company committed to excellence and innovation in the field of life-changing medicines. With a global team and a pioneering spirit, we provide individuals with unparalleled opportunities for growth, learning, and skill expansion. Our culture of...

  • Manufacturing Process Maintenance Specialist III

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job Title: Manufacturing Process Maintenance Specialist IIIAbout the CompanyBiogen is a leading biotechnology company committed to excellence and innovation in the field of life-changing medicines. With a global team and a pioneering spirit, we provide individuals with unparalleled opportunities for growth, learning, and skill expansion. Our culture of...

  • Sr. Manufacturing Control Specialist III

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This Role As the Sr Manufacturing Control Specialist III, you will be responsible for the oversight and maintenance of the risk assessments and technical assessments at Biogen's Research Triangle Park - Pharma Site. Reporting to the Head of Manufacturing – ASO and OSD, your expertise in microbiology,...

  • Manufacturing Sciences Engineer III

    1 week ago

    Triangle Township, United States Biogen Full time

    Job Title: Engineer III, Manufacturing SciencesBiogen is seeking a highly skilled Engineer III, Manufacturing Sciences to join our team. As a key member of our manufacturing operations, you will provide technical expertise to support clinical, PPQ, and commercial manufacturing campaigns.Key Responsibilities:Lead Process Transfer teams and technical...

  • Manufacturing Specialist III, MFG Tech Ops

    4 months ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout this RoleIn this Small Scale Manufacturing (SSM) Manufacturing Specialist III 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...

  • Manufacturing Process Maintenance Specialist III

    4 months ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionShift Information  This position will work a 2,2,3 schedule working the 12-hour Night Shift. About the Job  A Manufacturing Process Maintenance Specialist III will provide customer-oriented service and support in a fast-paced manufacturing environment. Performs corrective and preventative maintenance on...

  • Engineer III, Manufacturing

    4 months ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Engineer III designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.  The...

  • Manufacturing Process Maintenance Specialist II

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionA Manufacturing Process Maintenance Specialist III will provide customer-oriented service and support in a fast-paced manufacturing environment. Performs corrective and preventative maintenance on manufacturing Filling equipment, Isolators, Vial Washers, Autoclaves, Parts Washers, and Automatic Vial Inspection...

  • Manufacturing Specialist II

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewThis role involves working a 10-hour shift, either Monday to Thursday or Tuesday to Friday, with weekends required on a rotating schedule.A Manufacturing Specialist II will deliver customer-focused service and support within a dynamic manufacturing setting. Responsibilities include executing both corrective and preventative maintenance on various...

  • Manufacturing Operations Specialist II

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryAs a Manufacturing Specialist II within our Small Scale Manufacturing (SSM) team, you will play a crucial role in supporting manufacturing operations. Your responsibilities will encompass technical documentation, project oversight, and process enhancement. This role demands a keen attention to detail, exceptional technical writing...

  • Senior Manufacturing Operations Specialist

    1 month ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryAs a Senior Manufacturing Operations Specialist at Biogen, you will play a pivotal role in supporting large-scale manufacturing processes. This position involves a variety of responsibilities, including technical documentation, project oversight, and process enhancement. The ideal candidate will possess a keen attention to detail,...

  • Engineering Specialist III, Facilities

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryThe Facilities Engineer III plays a crucial role in delivering engineering support and validation for plant utilities and facilities. This position is integral to cross-functional teams aimed at enhancing existing processes and implementing necessary changes. Collaboration with various departments such as Utilities, Manufacturing,...

  • Manufacturing Process Maintenance Specialist II

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Process Maintenance Specialist II to join our team at Biogen. As a key member of our manufacturing operations, you will be responsible for providing customer-oriented service and support in a fast-paced manufacturing environment.Key ResponsibilitiesEquipment Maintenance: Perform corrective and...

  • Sr. Manufacturing Control Specialist III

    4 weeks ago

    Research Triangle Park, United States Biogen Full time

    About This Role As the Sr Manufacturing Control Specialist III, you will be responsible for the oversight and maintenance of the risk assessments and technical assessments at Biogen's Research Triangle Park - Pharma Site. Reporting to the Head of Manufacturing – ASO and OSD, your expertise in microbiology, manufacturing, and facility controls will play...

  • Co-op Parenteral Facility Manufacturing Specialist

    16 hours ago

    Triangle Township, United States Biogen Full time

    Job DescriptionThis is a 6-month student role from January to June 2025. Resume review begins in October 2024.The Parenteral Facility Manufacturing Technical Operations (MTO) Team supports the Parenteral Facility (PF) Manufacturing Department. We are a multicultural group of specialists who serve the PF as process experts by managing the documentation and...

  • Manufacturing Coordination Specialist

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewThis role is essential for overseeing daily manufacturing coordination and support functions aligned with Data Management, Manufacturing Assistance, and Continuous Improvement initiatives. Key responsibilities include managing material logistics, coordinating equipment, and ensuring compliance with batch records and documentation. The position...

  • Manufacturing Associate III-Visual Inspection

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis position will work a four day, ten hour shift- 6a-4p Monday to Thursday each weekAbout This RoleManufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a...

  • Manufacturing Operations Specialist

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Technician II to join our team at Biogen. As a key member of our manufacturing operations, you will be responsible for providing customer-oriented service and support in a fast-paced environment.Key ResponsibilitiesEquipment Maintenance: Perform corrective and preventative maintenance on manufacturing...

  • Manufacturing Operations Specialist

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryBiogen is seeking a skilled Manufacturing Associate to join our team in the Parenteral Filling operations at our facilities. As a key member of our manufacturing team, you will play a crucial role in delivering life-saving therapies to patients in need.Key ResponsibilitiesExecute daily manufacturing activities according to cGMP Standard Operating...

  • Manufacturing Associate III-Parenteral Filling

    3 months ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis position will work 12-hour DAY SHIFTS (approx. 6:00am - 6:00pm) on a 2-2-3 rotationAbout This RoleManufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person...