Supervisor - Aseptic Operations

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 lead the aseptic training and certification team and own the site aseptic qualification program, ensuring personnel are trained, qualified, and maintained in certification for aseptic gowning, aseptic behaviors, contamination control practices, cleanroom operations, and interventions. Accountable for the compliance and inspection readiness of the program and for strengthening aseptic processing performance and product sterility assurance. 

Key Activities/Responsibilities:

Training Program Administration

• Own, develop, and maintain the site aseptic training and certification programs, curricula, and qualification matrices.
• Deliver and oversee instructor-led training, practical demonstrations, virtual reality modules, and hands-on assessments; qualify and monitor other trainers for consistent delivery.
• Plan, resource, and manage new hire qualifications, annual recertification, and retraining for all personnel requiring cleanroom access, tracking completion and escalating at-risk personnel.
• Certification and Qualification.
• Set competency standards and oversee evaluation through written exams, practical assessments, and observation-based audits; final approver for certification and de-certification.
• Direct operator qualification and certification for media fills and aseptic interventions, partnering with Manufacturing and Microbiology.
• Ensure certification records and training databases are accurate, complete, and inspection ready.

Aseptic Compliance and Auditing

• Manage the observation and audit schedule for personnel in Grade A/B and C/D environments, performing higher-risk observations directly.
• Trend and report compliance with gowning, aseptic technique, cleanroom behaviors, and contamination control; ensure coaching, corrective actions, and follow-up training are completed and effective.
• Support investigations of aseptic technique deviations, contamination events, and environmental monitoring trends, owning training-related CAPAs; represent the program in regulatory, corporate, and customer audits and maintain alignment with cGMPs, FDA aseptic processing guidance, and EU GMP Annex 1.

• Team Leadership and Coaching.
• Provide day-to-day direction to the aseptic training team, including work assignment, scheduling, prioritization, and workload balancing.
• Coach, mentor, and develop trainers and cleanroom personnel on aseptic practices, contamination prevention, first-air protection, and cleanroom discipline; support recruitment, onboarding, goal setting, and performance feedback for the team.
• Serve as site subject matter expert and escalation point for aseptic processing and contamination control training, partnering with supervisors, managers, and site leadership to identify training needs and agree remediation plans.
• Report program metrics to site leadership, author and approve SOPs and curricula as process owner, lead continuous improvement of training methods, and champion a culture of quality and compliance.
• Lead and support departmental projects and perform other tasks and duties as assigned.

Qualifications/Training:

• High School diploma required; associate or bachelor’s degree in science or a related field preferred.
• Detail oriented, highly organized.
• Able to maintain confidentiality.
• Effective written, verbal, and presentation skills.
• Strong interpersonal, coaching, time management, and follow through abilities.
• Effective problem solver with proven leadership and team development abilities.

Experience:

• 10+ years pharmaceutical cleanroom experience, including 3+ years leading or coordinating a team.
• Program management, training course design, delivery, and effectiveness assessment.
• Thorough knowledge of proper aseptic techniques, gowning qualification, media fill programs, cGMPs, and applicable aseptic processing guidance (FDA aseptic processing guidance, EU GMP Annex 1). Audit and inspection support experience preferred.

Eligibility for Internal Applicants:

Have no corrective actions at the written warning level in last six months / no final warning level in the last 12 months / no active PIP. 
Meet the qualifications of the position as stated above.                                                     
Be in your current job for 12 months.

Position applying for must be a step up in progression and not a step down.       

This position may be available in the following location(s): US - Tampa, FL

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.

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To learn more please read Bausch + Lomb's Job Offer Fraud Statement

Our US Benefit Programs Employee Benefits: Bausch + Lomb

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.