Validation Engineer
Intellectt INC
Title: Validation Engineer
Location: Albany, NY
Job Summary:
We are seeking a Validation Engineer with hands-on experience in VHS (Vaporized Hydrogen Peroxide) and Smoke Studies to support validation activities in a regulated environment. Candidates must have direct experience planning, executing, documenting, or supporting VHS and smoke study validation activities.
Key Responsibilities
Support and execute VHS (Vaporized Hydrogen Peroxide) validation studies.
Perform and/or support smoke studies for airflow visualization and validation.
Develop and review validation protocols, test plans, and reports.
Execute validation activities according to approved protocols and established procedures.
Document test results, observations, deviations, and conclusions accurately.
Support investigation and resolution of validation deviations or discrepancies.
Work with cross-functional teams to ensure validation activities are completed on schedule.
Maintain validation documentation in accordance with applicable quality and regulatory requirements.
Required Qualifications
Experience as a Validation Engineer / Validation Consultant in a regulated manufacturing or life sciences environment.
Mandatory: Hands-on VHS / Vaporized Hydrogen Peroxide validation experience.
Mandatory: Hands-on Smoke Study experience.
Experience with validation protocols, execution, documentation, and final reports.
Strong understanding of validation processes and good documentation practices.
Ability to work onsite in Albany, NY.
Available to start ASAP Preferred
Experience in pharmaceutical, biotech, medical device, or other GMP-regulated environments.
Experience with cleanrooms, controlled environments, environmental qualification, or aseptic processing.
Familiarity with GMP documentation and deviation/change-control processes.
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