Manufacturing Associate II, Parenteral Filling (Days)

Biogen•Research Triangle Park, NC

9d•Onsite

About The Position

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by key steps in the biomanufacturing process. Parenteral Filling Manufacturing Associates execute critical aseptic operations in a controlled cleanroom environment governed by Current Good Manufacturing Practices (cGMP).

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

Nice To Haves

Understanding of aseptic technique and cleanroom practices is preferred
Prior Parenteral Filling experience
Experience with LIMS systems

Responsibilities

Operation of automated and semi-automated filling lines
Component preparation, setup, and changeover activities
Environmental monitoring and in-process controls
Compounding of drug solutions and buffers
Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
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.
Create and revise key documentation like batch records, SLRs, and equipment logbooks
Assist with in-process sampling and basic analytical testing as required.
Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
Be a team player and leader; always showing up to contribute your energy and focus
Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Benefits

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