Lead, Aseptic Training & Compliance

Bausch & Lomb GmbH; Tampa (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Bausch + Lomb in Tampa, FL seeks a senior leader to own the aseptic training and certification program, ensuring personnel are trained, qualified, and certified for aseptic gowning and cleanroom operations.

The role requires 10+ years in pharmaceutical cleanrooms, strong leadership, and a track record of program management, cGMP guidance, and audits. The incumbent will drive certification metrics and continuous improvement in a high‑stakes environment.

Qualifications

• High School diploma required; associate or bachelor’s degree in science or a related field preferred.
• Detail oriented and 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.

Responsibilities

• 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.
• Certification and Qualification oversight and final approver for certification/ 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.
• Manage the observation and audit schedule for personnel in Grade A/B and C/D environments.
• Trend and report compliance with gowning, aseptic technique, and contamination control; drive CAPAs.
• Represent program in regulatory, corporate, and customer audits; align with cGMPs and FDA/EU guidelines.
• Lead and coach the aseptic training team; prioritize workload and develop trainers.
• Report program metrics to site leadership; author SOPs and drive continuous improvement.

Skills

Detail oriented

Organized

Written communication

Verbal communication

Presentation skills

Interpersonal skills

Coaching

Time management

Follow-through

Problem solving

Education

High School diploma

Associate or Bachelor’s degree in science or related field preferred

Job description

Bausch + Lomb in Tampa, FL seeks a senior leader to own the aseptic training and certification program, ensuring personnel are trained, qualified, and certified for aseptic gowning and cleanroom operations.

The role requires 10+ years in pharmaceutical cleanrooms, strong leadership, and a track record of program management, cGMP guidance, and audits. The incumbent will drive certification metrics and continuous improvement in a high‑stakes environment.