Sterilization Support Consultant

Responsibilities

• Serve as the subject-matter expert for sterilization processes.
• Provide technical guidance and oversight to ensure compliance with regulatory, quality, and industry standards.
• Support sterilization validation, dose audits, sample planning, requalification activities, and coordination with external sterilization providers.
• Provide technical support to QC Microbiology through sterility-test review and laboratory-investigation support.
• Assess microbiological findings associated with post-sterilization product performance.
• Lead and support sterilization-related projects, technical assessments, risk evaluations, and corrective actions.
• Identify and address sterilization compliance gaps and process-improvement opportunities.
• Develop and deliver training covering sterilization processes, vendor coordination, sample requirements, and execution best practices.
• Support internal teams in building consistent and compliant sterilization practices.

Qualifications

• Bachelor's degree in Microbiology, Biology, Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
• 7+ years of experience supporting sterilization programs in a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
• Expertise in sterilization validation, dose audits, requalification, sterility assurance, sample requirements, and coordination with contract sterilization providers.
• Strong knowledge of sterility testing, microbiological investigations, post-sterilization microorganism assessments, and microbial-control requirements.
• Ability to lead technical assessments, troubleshoot sterilization issues, support regulatory inspections and audits, and train cross-functional teams.

Pay

TBD

Schedule

Varies

Benefits

Commensurate with experience