EsteemIT · 1 day ago
Aseptic & Terminal Sterilization Expert – Sterile Injectables
Boca Raton, FL
Contract
Onsite
Senior Level
7+ years expEsteemIT is seeking an Aseptic and Terminal Sterilization Expert with strong technical and hands-on experience in aseptic processing and sterile injectable manufacturing. The role involves providing technical leadership for sterilization operations, ensuring compliance with regulatory guidelines, and collaborating with various teams to maintain sterility assurance standards.
Information Technology & Services
Hiring Manager
Sujan Palle
Responsibilities
Provide technical leadership for aseptic and terminal sterilization operations
Oversee lyophilization and isolator-based sterile vial filling processes
Ensure full compliance with cGMP, aseptic techniques, sterility assurance, and regulatory guidelines
Develop, review, and optimize SOPs, sterilization cycles, and validation protocols
Support cycle development, PQ, validation, and revalidation activities
Review batch records and ensure sterility assurance standards are maintained
Lead and support media fills, EM programs, sterility assurance reviews, and audits
Investigate deviations, root-cause analysis, and implement CAPAs
Provide training and mentorship on aseptic & sterilization best practices
Collaborate closely with Quality, Validation, Engineering, and Production teams
Qualification
Required
Bachelor's / Master's in Pharmacy, Biotechnology, Microbiology, Chemical Engineering, or related field
7+ years of experience in sterile injectable / aseptic manufacturing
Proven expertise in: Aseptic processing & sterility assurance
Proven expertise in: Terminal sterilization (e.g., steam/autoclave validation)
Proven expertise in: Lyophilization operations
Proven expertise in: Isolator-based vial filling systems
Strong knowledge of FDA, EU GMP, WHO, Annex 1 requirements
Experience in investigations, deviations, risk assessments & documentation
Preferred
Experience with DARA vial filling machines preferred
Company
EsteemIT
Welcome to EsteemIT! We are a rapidly growing IT consulting organization certified as a Women's Business Enterprise (WBE) and a Minority Business Enterprise (MBE), providing top-notch and dependable end-to-end IT solutions.
2-10 employees
H1B Sponsorship
EsteemIT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (3)
2022 (16)
Funding
Current Stage
Early StageCompany data provided by crunchbase