Job Description
Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Sterilization Support Consultant.
Position Type:
- Contract
- Onsite
Required
- Bachelor's degree in Microbiology, Biology, Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
- 7+ years of experience supporting sterilization programs within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
- Demonstrated expertise in sterilization validation, dose audits, requalification activities, sterility assurance, sample requirements, and coordination with contract sterilization vendors.
- Strong knowledge of sterility testing, microbiological investigations (LIRs), post-sterilization microorganism assessments, and regulatory expectations for sterilization and microbial control.
- Proven ability to lead technical assessments, troubleshoot sterilization-related issues, support regulatory inspections and audits, and train cross-functional teams on sterilization processes and compliance requirements.
Responsibilities:
- Serve as the subject matter expert (SME) for sterilization processes, providing technical guidance and oversight to ensure compliance with applicable regulatory, quality, and industry standards.
- Support sterilization program activities, including sterilization validation, dose audits, sample planning, requalification activities, and coordination with external sterilization vendors.
- Provide technical expertise for QC Microbiology by reviewing sterility testing, supporting laboratory investigations (LIRs), and assessing microbiological findings related to post-sterilization product performance.
- Lead and support sterilization-related projects, assessments, risk evaluations, and corrective actions to address compliance gaps and improve sterilization processes at the Hayward site.
- Develop and deliver training on sterilization processes, vendor coordination, sample requirements, and best practices to strengthen internal capabilities and ensure consistent execution.