Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.