Intellectt Inc · 8 hours ago
Validation Specialist
Albany, NY
Contract
Onsite
Mid LevelIntellectt Inc is seeking a Validation Engineer with strong Vaporized Hydrogen Peroxide (VHP) experience to support critical sterility assurance and equipment qualification activities within a regulated manufacturing environment. This role is essential for maintaining validated sterile conditions in aseptic processing areas and requires a balance of execution and technical documentation responsibilities.
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Hiring Manager
Sai Eswar
Responsibilities
Execute VHP qualification and requalification activities across multiple systems and controlled environments
Support sterility assurance efforts for filling lines, material transfer systems, and QC isolators
Perform hands-on validation execution, including VHP cycle development, preparation, and implementation
Lead or assist in qualification of new filling lines and requalification of existing production lines
Prepare and review validation documentation, including:
Validation protocols
Summary reports
Risk assessments
Updates to internal validation guidelines and procedures
Collaborate with cross-functional teams to ensure compliance with GMP and regulatory standards
Support a high volume of upcoming validation activities requiring strong execution focus
Qualification
Required
Hands-on experience with Vaporized Hydrogen Peroxide (VHP) validation/qualification
Strong background in equipment, process, or cleaning validation execution
Experience working in GMP-regulated pharmaceutical, biotech, or life sciences environments
Solid technical writing skills for validation protocols and reports
Ability to work 100% onsite on 1st shift, with flexibility to support 2nd shift when needed
Preferred
Experience with ValGenesis validation lifecycle management system
Prior experience supporting aseptic processing or sterile manufacturing environments
Familiarity with filling lines, isolators, and material transfer systems
Company
Intellectt Inc
Intellectt Inc.
Founded in 2018
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