Manufacturing Associate II / III, Visual Inspections and Packaging (Days)
Biogen
Summary
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Visual Inspection area in the Drug Product (Parenteral Filling) facility in Research Triangle Park (RTP). The Visual Inspection Manufacturing Associates is responsible for performing manual and/or automated visual inspection of sterile drug product containers (vials, syringes, and cartridges) to ensure product quality and compliance with GMP requirements.
Job description
What You'll Do
- Perform manual visual inspection of finished drug product units according to approved SOPs and work instructions
- Operate automated inspection equipment and support automated inspection activities
- Perform area setup, line clearance, and inspection booth verification activities
- Execute bulk packaging related activities
- Accurately document and record all cGMP data and information, including deviations, for processing steps and equipment activities
- Create and revise key documentation such as batch records, SLRs, and equipment logbooks
- Assist with in-process sampling and basic analytical testing as required
- Maintain a clean, safe, and compliant manufacturing environment
- Maintain a clean, safe, and compliant work environment, with a strong focus on inspection and audit readiness
- Collaborate effectively as a team member and demonstrate leadership through engagement, accountability, and operational excellence
- Actively participate in and support training and development initiatives for both personal growth and the development of team members
Who You Are
You're driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills for a Manufacturing Associate II
- Bachelor's degree from an accredited college or university, STEM preferred and 0+ years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience
- A High School Diploma (or equivalent) and at minimum of .5 years of direct experience
- Previous experience in a GxP environment
- Ability to follow SOPs and work effectively on shift schedules if required
- Demonstrated documentation and data integrity skills
- Understanding of GMP and cleanroom practices is preferred
Required Skills for a Manufacturing Associate III
- Bachelor's degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Demonstrated experience working in a cGMP environment
- Strong documentation, compliance, and process execution skills
- Ability to lead tasks, support teams, and collaborate effectively across shifts
- Experience with cGMP and cleanroom practices
Preferred Skills
- Prior Parenteral Filling experience
- Experience with TrackWise, DeltaV, and LIMS systems
Requirements
- Bachelor's degree from an accredited college or university, STEM preferred and 0+ years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience
- A High School Diploma (or equivalent) and at minimum of .5 years of direct experience
- Previous experience in a GxP environment
- Ability to follow SOPs and work effectively on shift schedules if required
- Demonstrated documentation and data integrity skills
- Understanding of GMP and cleanroom practices is preferred
- Bachelor's degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Demonstrated experience working in a cGMP environment
- Strong documentation, compliance, and process execution skills
- Ability to lead tasks, support teams, and collaborate effectively across shifts
- Experience with cGMP and cleanroom practices
- Prior Parenteral Filling experience
- Experience with TrackWise, DeltaV, and LIMS systems
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.