Intellectt Inc · 2 days ago
Validation Engineer- Aseptic / Sterile Injectables
Florida, United States
Contract
Onsite
Mid, Senior Level
4+ years expIntellectt Inc is seeking a Validation Engineer specializing in Aseptic and Sterile Injectables. The role involves supporting aseptic process validation activities for sterile injectable products, focusing on vial filling and fill-finish operations in a cGMP manufacturing environment.
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Hiring Manager
Venkat Chinta
Responsibilities
Support aseptic process validation for sterile injectable and vial filling operations
Execute and document media fills, process validations, and cleaning validations
Prepare and review IQ/OQ/PQ protocols and validation reports
Support aseptic vial filling line validations, including filling, stoppering, and capping processes
Participate in deviation investigations, CAPA, and risk assessments related to validation
Ensure compliance with cGMP, FDA, and regulatory requirements
Collaborate with Manufacturing, QA, and Engineering during validation execution
Qualification
Required
4–8 years of validation experience in sterile injectable manufacturing
Hands-on experience with aseptic vial filling operations
Strong knowledge of media fills and fill-finish validation
Solid understanding of cGMP and FDA regulations
Strong documentation and technical writing skills
Company
Intellectt Inc
Intellectt Inc.
1001-5000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
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2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase