What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
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
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.
- 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.
