Senior GMP Validation Engineer – Lead & Compliance

Kriya Therapeutics, Inc.; Milwaukee (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Time Off & Leave

Medical, Dental, Vision Insurance

Life Insurance

401(k) with Company Match

Equity & Identity Theft Protection

Job summary

Kriya Therapeutics, Inc. seeks a Senior Validation Engineer to lead our validation program for GMP equipment and facilities. You will author and execute validation plans, protocols, and procedures across equipment, facilities, and utilities, ensuring alignment with EU and FDA requirements.

You will guide risk assessments, coordinate with cross-functional teams, and mentor junior staff while staying current on regulatory guidelines to ensure ongoing compliance.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 6–8+ years in validation/qualification of GMP equipment and facilities.
• Solid knowledge of EU and FDA GMP validation guidelines.
• Experience writing/ executing validation protocols and reports.
• Familiarity with risk assessment methodologies in validation.
• Strong collaboration with cross-functional teams.

Responsibilities

• Develop and execute validation plans for GMP equipment, facilities, utilities, and critical systems per EU/FDA requirements.
• Author IQ/OQ/PQ protocols, perform testing, analyze data, and generate reports.
• Support and improve the validation strategy and roadmap with leadership.
• Maintain GMP validation policies, procedures, and best practices.
• Collaborate with Manufacturing, QA, QC, Engineering, Facilities, Regulatory Affairs, OT, and CSV teams.
• Conduct risk assessments and create validation plans for critical systems.
• Coordinate with external vendors/contractors for validation projects.
• Stay updated on EU and FDA regulations and advise on changes.

Skills

Validation expertise

Regulatory knowledge (EU/FDA)

Protocol development

Risk assessment

Cross-functional collaboration

Attention to detail

Biotech/pharma experience

Mentoring/leadership

Education

Bachelor's degree in Science/Engineering

Tools

Kneat Gx

Job description

Kriya Therapeutics, Inc. seeks a Senior Validation Engineer to lead our validation program for GMP equipment and facilities. You will author and execute validation plans, protocols, and procedures across equipment, facilities, and utilities, ensuring alignment with EU and FDA requirements.

You will guide risk assessments, coordinate with cross-functional teams, and mentor junior staff while staying current on regulatory guidelines to ensure ongoing compliance.