Aseptic Training & Compliance Leader

Bausch & Lomb GmbH

Tampa (FL)

Hybrid

USD 110,000 - 150,000

Full time

9 hours ago

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Job summary

Bausch & Lomb GmbH in Tampa, FL seeks an experienced leader to own the aseptic training and certification program, ensuring personnel are trained, qualified, and certified for aseptic gowning and cleanroom operations. You will collaborate with Manufacturing and Microbiology to strengthen sterility assurance and inspection readiness.

The role requires extensive cleanroom experience, leadership ability, and deep knowledge of cGMPs, FDA guidance, and EU Annex 1.

Qualifications

10+ years pharmaceutical cleanroom experience.
3+ years leading or coordinating a team.
Thorough knowledge of cGMPs and applicable aseptic processing guidance (FDA/EU).

Responsibilities

Own, develop, and maintain the site aseptic training and certification programs, curricula, and qualification matrices.
Deliver and oversee instructor-led training, practical demonstrations, and hands-on assessments; qualify and monitor trainers.
Plan, resource, and manage new hire qualifications, annual recertification, and retraining for cleanroom access.
Direct operator qualification and certification for media fills and aseptic interventions.
Ensure certification records and training databases are accurate and inspection ready.
Lead and coach the aseptic training team and report program metrics to site leadership.