Aseptic Filling Training Associate

Bausch+Lomb Companies Inc.•Greenville, SC

About The Position

The Aseptic Filling Training Associate oversees aseptic manufacturing processes, providing quality control and operational support in the aseptic core. The role ensures compliance with cGMP and provides real-time oversight and training to help maintain product quality and safety. The associate monitors aseptic manufacturing and gowning practices, documents and reviews process data, and supports investigations into aseptic technique deviations, contamination events, and environmental monitoring trends. The role also supports training and qualification activities, including new-hire qualifications, annual recertification, retraining, media fill observations, and follow-up coaching. Working with Operations, Quality, and other departments, the associate serves as a site subject matter expert and escalation point for aseptic processing and contamination-control training. The position promotes teamwork, continuous improvement, and a Right First Time mindset, and may support departmental projects and other assigned duties. The position may be available in Greenville, South Carolina.

Requirements

High school diploma required.
At least 5 years working in and/or supporting aseptic operations under cGMP scrutiny.
Experience with aseptic operations including cleaning and sanitization, sterilization, aseptic gowning and technique, operating principles, non-conformance investigation, process validation, environmental testing, and equipment operation in an aseptic environment.
Familiarity with applicable aseptic processing guidance, such as FDA CFR and EU GMP Annex 1.
Strong communication, conflict-resolution, and critical-thinking skills.
Detail oriented and highly organized.
Effective problem solver with demonstrated leadership and team-development abilities.
Must be authorized to work for any employer in the United States; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

Associate or bachelor’s degree in science, such as microbiology, or a related field.

Responsibilities

Monitor and support aseptic manufacturing activities, ensuring adherence to SOP and cGMP requirements and correcting or escalating issues as they occur.
Observe area personnel performing aseptic gowning, provide immediate positive and constructive feedback, and instruct personnel to restart the gowning process when necessary.
Record, track, and review data, completing documentation in accordance with cGDPs.
Support investigations concerning aseptic technique deviations, contamination events, and environmental monitoring trends.
Support instructor-led training, practical demonstrations, virtual reality modules, and hands-on assessments.
Support new-hire qualifications, annual recertification, and retraining for aseptic core personnel.
Observe and record aseptic technique performance during media fill simulations.
Trend and report data related to aseptic gowning, aseptic technique, cleanroom behaviors, and contamination control; ensure coaching, corrective actions, and follow-up training are completed and effective.
Provide immediate feedback, corrective action training, and mentorship to aseptic core personnel.
Work with Operations, Quality, and other departments, communicating openly and escalating matters when necessary.
Improve team knowledge of microbiological science, control strategies, monitoring programs, and their impact on aseptic processing.
Serve as the site subject matter expert and escalation point for aseptic processing and contamination-control training; partner with area Team Leads and Group Leads to identify training needs and agree on remediation plans.
Promote teamwork and collaboration, continuous improvement, and a Right First Time mindset.
Support departmental projects and perform other assigned tasks and duties.