Visual Inspection Validation

6 days ago

Hyderabad, India Tek Support Full time

Job Title: Senior Validation Engineer – Visual Inspection SystemsLocation: RemoteClient: Regeneron PharmaceuticalsOverview:Seeking an experienced Validation Engineer to support visual inspection system qualification and requalification activities within Regeneron’s fill-finish operations. The role involves developing and executing validation deliverables for semi-automatic and fully automatic inspection equipment and ensuring alignment with cGMP and corporate standards. This position requires a high degree of technical expertise to complement a team of mid-level validation contractors.Key Responsibilities:Developed, reviewed, and executed validation protocols (IQ/OQ/PQ) and requalification programs for visual inspection systems in sterile manufacturing.Supported SAT and commissioning activities for semi-automatic syringe inspection (SASI), semi-automatic vial inspection (SAVI), and SWITCH systems.Created equipment-specific validation documentation from the ground up, ensuring templates and protocols accurately reflected fill-finish processes rather than bulk manufacturing setups.Evaluated and optimized inspection system performance through Knapp studies, ensuring consistent visual inspection accuracy and reliability.Authored technical reports, risk assessments, and validation summaries in compliance with FDA, EU Annex 1, and internal quality standards.Collaborated with automation, quality, and manufacturing teams to troubleshoot equipment performance issues and drive continuous improvement in inspection reliability.Established and maintained a requalification strategy for automated inspection systems, incorporating data-driven lifecycle management principles.Provided mentorship and technical guidance to junior validation engineers and contractors.

  • Visual Inspection Validation

    5 days ago

    Hyderabad, India Tek Support Full time

    Job Title: Senior Validation Engineer – Visual Inspection Systems Location: Remote Client: Regeneron Pharmaceuticals Overview: Seeking an experienced Validation Engineer to support visual inspection system qualification and requalification activities within Regeneron's fill-finish operations. The role involves developing and executing validation...

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