Intellectt Inc · 5 days ago
Validation Engineer – Aseptic / Sterile Injectables
Boca Raton, FL
Contract
Onsite
Mid, Senior Level
4+ years expIntellectt Inc is seeking a Validation Engineer to support aseptic process validation activities for sterile injectable products in a cGMP manufacturing environment. This role focuses on ensuring validated and compliant manufacturing processes, particularly in vial filling and fill-finish operations.
Information TechnologyRecruitingStaffing Agency
Hiring Manager
Uday Katari
Responsibilities
Support aseptic process validation for sterile injectable manufacturing, with emphasis on vial filling and fill-finish operations
Execute and document media fills, process validations, and cleaning validations
Author, review, and approve IQ/OQ/PQ protocols, validation plans, and final reports
Support validation of aseptic vial filling lines, including filling, stoppering, and capping processes
Participate in deviation investigations, root cause analysis, CAPA activities, and risk assessments related to validation
Ensure validation activities comply with cGMP, FDA, and applicable regulatory requirements
Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other stakeholders during validation execution
Qualification
Required
4–8 years of hands-on validation experience within sterile injectable manufacturing environments
Direct experience supporting aseptic vial filling and fill-finish operations
Strong working knowledge of media fills and aseptic process validation
Solid understanding of cGMP, FDA regulations, and industry best practices
Excellent documentation, technical writing, and communication 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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Funding
Current Stage
Late StageCompany data provided by crunchbase