Katalyst CRO

Validation Engineer

Philadelphia, PA, US

2 months ago
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Summary

Job Summary

The Validation Engineer is responsible for executing equipment and system validation activities within a regulated biopharmaceutical environment. This role involves implementing validation protocols, documenting results, and ensuring compliance with regulatory requirements. The position is based in West Philadelphia, Pennsylvania with a hybrid work arrangement.

Responsibilities

  • Proficiency in Kaye AVS validation software.
  • Experience with Valpro validation management systems.
  • Competence in Kneat Veeva validation documentation platform.
  • Expertise in temperature excursion analysis and mitigation.
  • Validation protocol execution and documentation.
  • Regulatory compliance management.

Requirements:

  • Minimum 3+ years of relevant validation engineering experience.
  • Experience in biopharmaceutical industry preferred.
  • Demonstrated expertise with validation software platforms (Kaye AVS, Valpro, Kneat Veeva).
  • Proven capability in temperature exercising validation activities.
  • Knowledge of cGMP requirements and regulatory standards.

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