What You'll Do
Lead the design, execution, and continuous improvement of the facility’s Environmental Monitoring (EM) Program, ensuring alignment with current regulatory standards. Develop and maintain SOPs, sampling plans, and validation protocols for ISO Class 5, 7, and 8 environments.
Provide expert guidance on cleaning and disinfection practices, including the evaluation of disinfectant efficacy. Oversee media qualification, incubation procedures, and microbial readings, ensuring accurate detection, enumeration, and interpretation of microbial growth.
Investigate microbial excursions using root cause analysis and implement corrective and preventive actions. Maintain a microbial flora database and conduct trending to support contamination control strategies. Train and supervise staff involved in EM activities, with a focus on aseptic technique and compliance.
Act as the primary microbiology contact for third-party laboratories, coordinating testing, reviews, and audit support. Maintain complete, accurate records and reports to meet inspection readiness. Stay current with evolving regulations, testing methodologies, and monitoring technologies in pharmaceutical microbiology.
Requirements
- Bachelor’s degree or higher in Microbiology, Pharmacy, or a related life science field
- Minimum of 5 years of hands-on experience in aseptic processing environments within pharmaceutical, biotech, or compounding settings
- Direct experience working in ISO Class 5 or more stringent cleanroom environments
- Thorough knowledge of cGMP, USP <797>, <800>, <1116>, and FDA 503A/503B regulatory frameworks
- Proven ability to lead microbial investigations and interpret environmental data
Preferred Qualifications
- Experience managing end-to-end EM programs from development through daily operations
- Familiarity with viable and non-viable particle monitoring systems and air/surface sampling techniques
- Hands-on use of microbiology lab equipment and experience interpreting microbial identification results
- Strong analytical, documentation, and cross-functional collaboration skills
- Background in setting up new microbiology laboratories, including staffing and procedure development
- Experience supporting regulatory audits by agencies such as FDA, BOP, or PCAB
Benefits
- Competitive salary and equity compensation for eligible roles
- Unlimited paid time off, company-observed holidays, and quarterly mental health days
- Comprehensive medical, dental, and vision coverage
- Generous parental leave policy
- Employee Stock Purchase Program (ESPP)
- 401(k) plan with employer matching
