Aseptic Filling Training Associate

Bausch & Lomb GmbH; Greenville (SC); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Bausch + Lomb is seeking an experienced professional to oversee aseptic manufacturing processes with a focus on quality control and operational support in the aseptic core.

You will train and qualify aseptic personnel, monitor gowning and contamination controls, and partner with Operations and Quality to drive continuous improvement and Right First Time performance.

Qualifikationen

• Strong communication, conflict resolution, and critical thinking.
• Detail oriented and highly organized.
• Effective problem solver with leadership and team development abilities.

Aufgaben

• Process Oversight: monitor aseptic manufacturing activities and ensure cGMP/SOP adherence; escalate issues.
• Certification and Qualification: support instructor-led training, qualifications, retraining for aseptic core personnel.
• Coaching and Continuous Improvement: provide feedback and mentorship; drive continuous improvement and Right First Time mindset.
• Other: support departmental projects and related duties as assigned.

Jobbeschreibung

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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives/Purpose of Job:

To oversee aseptic manufacturing processes, acting as both a quality control and operational support role in the aseptic core, ensuring compliance with cGMP, and providing real-time oversight and training to maintain product quality and safety.

Key Activities/Responsibilities :

Process Oversight

• Monitor and support aseptic manufacturing activities, ensuring adherence to SOP and cGMP requirements and correcting/escalating issues as they occur.
• Observe aseptic gowning performed by area personnel, providing immediate feedback (positive and constructive) to reinforce appropriate behaviors and correct improper actions; corrections may include instructing personnel to restart the gowning process.
• Record, track, and review data, completing all documentation in accordance with cGDPs.
• Support investigations concerning aseptic technique deviations, contamination events, and environmental monitoring trends.

Certification and Qualification

• Support the delivery of 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.

Coaching and Continuous Improvement

• Provide immediate feedback, corrective action training, and mentorship to aseptic core personnel.
• Work closely with Operations, Quality, and other departments, communicating openly and escalating matters when necessary.
• Improve team’s knowledge of microbiological science, control strategies, and monitoring programs and their impact on aseptic processing.
• Serve as site subject matter expert and escalation point for aseptic processing and contamination control training, partnering with area Team Leads and Group Leads to identify training needs and agree remediation plans.
• Promote teamwork and collaboration in order to help create a work environment that encourages continuous improvement and a Right First Time (RFT) mindset.

Other

• Support departmental projects and perform other tasks and duties as assigned.

Qualifications/Training:

Formal Education:

• Associate or bachelor’s degree in science (i.e. Microbiology) or a related field preferred

Skills:

• Strong communication, conflict resolution, and critical thinking
• Detail oriented, highly organized
• Effective problem solver with proven leadership and team development abilities

Experience:

• 5+ years working in and/or supporting aseptic operations under cGMP scrutiny; operations include but are not limited to cleaning and sanitization, sterilization, aseptic gowning, aseptic technique and operating principles, non-conformance investigation, process validation, environmental testing, and equipment operation in an aseptic environment
• Familiar with applicable aseptic processing guidance (i.e. FDA CFR and EU GMP Annex 1)

This position may be available in the following location: Greenville, SC

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.