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Manufacturing Specialist III, MFG Tech Ops - Durham, United States - Biogen
Description
Job DescriptionAbout the Role
In this Small Scale Manufacturing (SSM) Manufacturing Specialist III role, you will be responsible for various manufacturing support tasks such as technical writing, project management, and process implementation. This position entails being detail-oriented with exceptional technical writing skills and a mindset focused on continuous improvement.
Responsibilities:
- Authoring diverse manufacturing documentation like procedures, work instructions, logbooks, changeover protocols, batch production records, and solution lot records, meeting key stakeholder requirements with minimal supervision.
- Leading or participating in projects for project management and execution, ensuring timely completion.
- Utilizing technical expertise, judgment, and precedent to identify, troubleshoot, and resolve technical and operational issues effectively.
- Proactively identifying opportunities for continuous improvement, sharing knowledge across functions, and spearheading site implementation.
- Collaborating with various cross-functional groups to identify improvement opportunities, support technology transfers, and ensure production schedules are met.
- Initiating, overseeing, and managing manufacturing-focused change controls, CAPAs, and planned exceptions, with a focus on providing on-site support primarily during core business hours.
Who You Are:
If you are a highly meticulous individual with a solid grasp of technical processes, excellent technical writing skills, and expertise in manufacturing operations, you would be an excellent addition to our Manufacturing Technical Operations Team. This role offers the chance to collaborate and innovate with a group dedicated to improving patient lives.
Qualifications:
Required Skills:
- Bachelor's degree preferred in Life Sciences or Engineering with 3 years of relevant experience.
- Associates Degree or Bioworks Certificate with 5 years of relevant experience.
- High School Diploma or Equivalent with 7 years of relevant experience.
Preferred Skills:
- Previous experience in manufacturing, particularly in drug substance biologics, downstream or upstream operations.
- Understanding of business processes and the roles of cross-functional groups supporting manufacturing operations.
- Strong knowledge of quality and cGMP principles.
- Fundamental understanding of change control in cGMP environments.
- Intermediate to advanced skills in Microsoft Office, computer-based quality systems, and technical writing.
- Ability to interpret manufacturing process design documents along with excellent communication skills.
Additional Information:
Why Biogen?
Join our global team at Biogen, a mid-sized biotechnology company committed to excellence and innovation. We offer stability and resources while fostering an environment where individual contributions create a significant impact. Our team comprises talented individuals with unparalleled opportunities for growth, learning, and skills development. Together, we strive to deliver life-changing medicines, with each role playing a crucial part in our mission of caring deeply, achieving excellence, and changing lives. At Biogen, we prioritize building a culture of inclusion and belonging that mirrors the communities we serve. We value diverse backgrounds, cultures, and perspectives that make us a stronger and more innovative company. Our focus is on creating empowered and inspired teams where every employee contributes to our success. Learn more about our diversity, equity, and inclusion efforts and how we are dedicated to creating an inclusive workplace. Biogen is proud to be an E-Verify Employer in the United States.
