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 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 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...

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