Senior GMP Validation Engineer

Kriya Therapeutics, Inc.; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Time Off & Work-Life Balance

Health & Wellness Benefits

Equity & 401(k)

Job summary

Kriya Therapeutics, Inc. in RTP, NC seeks a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility.

You will author validation plans, IQ/OQ/PQ protocols, data analyses, and reports to ensure compliance with FDA and EU guidance and company standards. Collaborating with Manufacturing, Quality Assurance, Regulatory Affairs and IT, you will assess risk, drive continuous improvement, mentor junior staff, and prepare for internal and external

Qualifications

• Bachelor's degree or higher in a scientific or engineering discipline.
• 6-8+ years of experience in validation and qualification of GMP equipment and facilities.
• Solid working knowledge of EU and FDA regulations and guidelines pertaining to GMP equipment and facility validation and qualification.
• Demonstrated experience authoring and executing validation protocols, including data analysis and report generation.
• Working knowledge of risk assessment methodologies and their application to validation activities.

Responsibilities

• Develop validation approach for GMP equipment, facilities, utilities, and critical systems.
• Execute validation lifecycle: IQ/OQ/PQ, data analysis, report generation.
• Support development and upgrade of the validation strategy and roadmap.
• Maintain validation policies and best practices for GMP compliance.
• Collaborate with cross-functional teams to coordinate validation activities.
• Conduct risk assessments and develop validation plans based on criticality of systems.
• Coordinate with vendors for validation projects as needed.
• Review GMP documentation for accuracy and regulatory compliance.
• Stay updated on EU/FDA regulations and recommend updates.
• Assist with CAPAs, Change Controls, and Deviations as needed.
• Support regulatory inspections as Validation SME and guide corrective actions.
• Provide mentorship to junior validation engineers and technicians.

Skills

GMP validation

Regulatory awareness

Documentation

Cross-functional collaboration

Risk assessment

Attention to detail

GMP facilities knowledge

Kneat Gx

Education

Bachelor's degree or higher in a scientific or engineering discipline

Tools

Kneat Gx

Job description

Kriya Therapeutics, Inc. in RTP, NC seeks a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility.

You will author validation plans, IQ/OQ/PQ protocols, data analyses, and reports to ensure compliance with FDA and EU guidance and company standards. Collaborating with Manufacturing, Quality Assurance, Regulatory Affairs and IT, you will assess risk, drive continuous improvement, mentor junior staff, and prepare for internal and external