Responsibilities include:

Apply knowledge in microbiology, aseptic technique, gowning, microbial control, and environmental monitoring (EM) for controlled environments.

Conduct microbiological testing such as bioburden and endotoxin.

Provide technical writing support for microbial control documents including SOPs, validation and qualification documents (IQ/OQ/PQ), study protocols, and investigations.

Lead cross-functional discussions to support project completion and sterility assurance.

Utilize GMP computer systems for processing change controls, managing technical documents, and conducting data trending and metrics analysis.

Support the review of deviations, change controls, and CAPAs, actively participating in investigations and problem resolution.

Assist in developing and delivering training materials related to microbial control to various departments.

Assess Contract Manufacturing Organization deviations related to microbial control and review partner change notifications.

Occasional domestic and international travel may be required.

Qualifications:

Experience in aseptic formulation and drug product filling operations.

Project management, facility start-up, and new product introduction (NPI) experience.

Familiarity with clean utility systems and monitoring for microbial control.

Knowledge of regulatory guidelines, including Annex 1 and FDA guidance for drug products.

Experience with quality risk management tools such as HACCP, LOPA, and FMEA.

Experience developing processes for sterile drug product manufacturing, including sterility sampling, redundant filtration (SURF), and isolator operating practices.