Senior Validation Engineer, GMP & Compliance

Kriya Therapeutics, Inc.; North Carolina; Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

Health Insurance

401(k) with Company Match

Résumé du poste

Kriya Therapeutics, Inc. is seeking a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility in Research Triangle Park, NC.

The role ensures compliance with EU and FDA requirements, authoring plans, protocols, and reports while guiding cross-functional teams through complex validation projects. The role emphasizes collaboration with Manufacturing, QA, QC, Engineering, Facilities, Regulatory Affairs, OT and CSO Validation, and requires a

Qualifications

• 6-8+ years of validation and qualification experience in biotech/pharma.
• Bachelor's degree or higher in a scientific or engineering field.
• Strong knowledge of EU and FDA GMP regulations.
• Experience authoring validation protocols and data analysis.
• Familiarity with GMP cleanrooms and utilities.

Responsabilités

• Develop validation approaches for GMP equipment, facilities, utilities, and critical systems per EU/FDA requirements.
• Author and execute validation lifecycle (IQ/OQ/PQ), test execution, data analysis, and reports.
• Support validation strategy and roadmap with leadership; ensure compliance with GMP regulations.
• Maintain validation policies and best practices; collaborate with Manufacturing, QA, QC, Engineering, Facilities, Regulatory Affairs, and OT.
• Review GMP documentation for accuracy and regulatory compliance.
• Stay current with EU/FDA regulations and update practices accordingly.
• Participate in CAPAs, Change Controls, Periodic Reviews, and Deviations as needed.
• Provide guidance and mentorship to junior validation engineers and technicians.

Connaissances

Validation

GMP compliance

Risk assessment

Cross-functional collaboration

Formation

Bachelor's degree in science/engineering

Outils

Kneat Gx

Description du poste

Kriya Therapeutics, Inc. is seeking a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility in Research Triangle Park, NC.

The role ensures compliance with EU and FDA requirements, authoring plans, protocols, and reports while guiding cross-functional teams through complex validation projects. The role emphasizes collaboration with Manufacturing, QA, QC, Engineering, Facilities, Regulatory Affairs, OT and CSO Validation, and requires a