Visual Inspection Validation

Job Title:

Location:

Client:

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.