Manufacturing Associate III – Parenteral Filling (Nights)
About The Position
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: 12-hour shifts Nights: 6:00 PM – 6:00 AM Rotating 2-2-3 schedule Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product (Parenteral Filling) facility in Research Triangle Park (RTP). These teams are the backbone of our operations—each playing a critical role in delivering life-changing 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). What You’ll Do Parenteral Filling Operations Include Aseptic filling of drug product into vials, syringes, or cartridges Operation of automated and semi-automated filling lines Component preparation, setup, and changeover activities Environmental monitoring and in-process controls Visual inspection and bulk handling activities, as applicable Execute daily manufacturing activities, including operating process equipment and executing validation protocols in accordance with 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. Assist with in-process sampling and basic analytical testing as required. 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.
Requirements
- The following combinations of education and direct experience will be considered:
- Bachelor’s degree in Science, Technology, Engineering, or Mathematics (STEM) or a related field from an accredited college or university with a minimum of .5 years of direct experience
- BioWorks Certificate or associate’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited institution with a minimum of 1 year of direct experience
- High school diploma or equivalent with a minimum of 1.5 years of direct experience
- Demonstrated experience working in a cGMP manufacturing environment
- Strong documentation, compliance, and process execution skills
- Ability to lead tasks, support teams, and collaborate effectively across shifts
Nice To Haves
- Prior Parenteral Filling experience
- Experience with TrackWise, DeltaV, and LIMS systems
Responsibilities
- Aseptic filling of drug product into vials, syringes, or cartridges
- Operation of automated and semi-automated filling lines
- Component preparation, setup, and changeover activities
- Environmental monitoring and in-process controls
- Visual inspection and bulk handling activities, as applicable
- Execute daily manufacturing activities, including operating process equipment and executing validation protocols in accordance with 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.
- Assist with in-process sampling and basic analytical testing as required.
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
