Manufacturing Associate
About the role
The Manufacturing Associate supports sterile, aseptic fillfinish operations for prefilled syringe manufacturing within isolatorbased production lines. In this role, you execute GMP manufacturing activities, operate isolator equipment, and uphold product quality, safety, and compliance with all regulatory and internal standards. You work in a cleanroom environment, apply aseptic techniques, and contribute to the reliable production of pharmaceutical products that are critical to hospital systems and patients across the United States.
Responsibilities
- Operate and monitor isolatorbased fillfinish equipment used in the production of prefilled syringes.
- Perform aseptic operations, including component preparation and staging, line setup and changeovers, and filling, stoppering, and capping activities.
- Execute manufacturing processes in strict accordance with current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), batch records, and safety requirements.
- Perform routine inprocess checks and visual inspections to ensure product quality and process control throughout production runs.
- Complete accurate and timely documentation in batch records, logbooks, and electronic systems to maintain full traceability and compliance.
- Support environmental monitoring activities and consistently maintain proper aseptic technique.
- Identify and promptly escalate deviations, equipment issues, or process abnormalities to supervision and quality teams.
- Participate in deviation investigations, root cause analysis, and corrective and preventive action (CAPA) activities as required.
- Maintain cleanroom standards, including sustaining gowning qualification and performing housekeeping duties in classified areas.
- Collaborate with crossfunctional teams, including Quality, Engineering, and Maintenance, to support continuous operations and resolve technical issues.
- Support continuous improvement initiatives focused on enhancing safety, product quality, and operational efficiency.
Essential Skills
- Hands-on experience in sterile manufacturing environments, specifically working on isolatorbased production lines.
- Strong understanding of aseptic processing principles and the critical nature of sterile operations.
- Demonstrated experience with GMP or cGMP manufacturing practices in a regulated environment.
- Ability to perform aseptic gowning and maintain aseptic technique consistently in a cleanroom setting.
- Proficiency in following SOPs, batch records, and safety requirements with high attention to detail.
- Capability to operate and monitor complex manufacturing equipment and respond appropriately to alarms or abnormalities.
- Strong documentation skills, including accurate completion of batch records, logbooks, and electronic systems.
- Ability to identify, communicate, and escalate deviations, equipment issues, and process abnormalities in a timely manner.
- Willingness to participate in investigations, root cause analysis, and CAPA activities to support quality and compliance.
Additional Skills & Qualifications
- GMPfocused training or certification, such as bioworks certification, or previous GMP aseptic manufacturing experience.
- Experience supporting environmental monitoring activities in sterile or aseptic manufacturing environments.
- Familiarity with sterile operations, cleanroom housekeeping, and classified area maintenance.
- Comfort collaborating with crossfunctional teams such as Quality, Engineering, and Maintenance.
- Interest in continuous improvement initiatives focused on safety, quality, and operational performance.
- Motivation to take advantage of crosstraining opportunities to broaden manufacturing skills and experience.
Work Environment
This is an onsite role based in Wilson, North Carolina, working in a sterile, isolatorbased pharmaceutical manufacturing facility. You work primarily in classified cleanroom areas that require proper aseptic gowning and adherence to strict GMP and safety standards. The position follows a night shift schedule with a 232 rotation, providing structured hours in a continuous operations environment. The site offers multiple crosstraining opportunities to support professional development and growth in manufacturing experience, and operates with a focus on producing pharmaceutical products that are essential to hospital systems and patients nationwide. This is a Contract position based out of Wilson, NC.
Pay and Benefits
The pay range for this position is $22.00 - $22.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Application deadline: Oct 7, 2026.