Senior CSV Manager: Software Validation & Compliance

Kriya Therapeutics, Inc.; Northern (KY); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Time Off & PTO

Health & Wellness Benefits

401(k) with Company Match

Job summary

Kriya Therapeutics, Inc. seeks a Manager, Computer Software Assurance & Validation to lead the CSV program at our Research Triangle Park site. You will set validation strategy, drive continuous improvement, and ensure data integrity across computerized systems throughout planning, testing, and retirement.

You will partner with QA, Manufacturing, Automation, and Facilities to ensure compliance with FDA/cGMP requirements and CSA testing approaches, supporting on-time system go-lives.

Qualifications

• Minimum bachelor’s degree in engineering or life science related field.
• 7+ years CSV experience in cGMP pharmaceutical or biopharmaceutical environments.
• Deep knowledge of FDA regulations (21 CFR Part 11, Part 820), GAMP 5, and risk-based CSV.
• Experience validating domain- and process-controlled systems, monitoring/alarm systems, historians, and test automation tools/frameworks.
• Strong data integrity knowledge and regulatory inspection support.

Responsibilities

• Lead the CSV program and drive continuous improvement across validated systems.
• Develop and approve CSV documentation (VMP, URS, FAT/PAT, IQ/OQ/PQ) per CSA approach.
• Ensure compliance with 21 CFR Part 11, Annex 11, and regulatory expectations.
• Partner with QA, Manufacturing, and IT to sustain data integrity and validated state.
• Oversee system inventory, change control, and periodic reviews across GMP environments.

Skills

Communication

Technical writing

Time management

Interpersonal skills

Leadership

Education

Bachelor's degree in engineering or life sciences

Tools

Test automation tools/frameworks

Job description

Kriya Therapeutics, Inc. seeks a Manager, Computer Software Assurance & Validation to lead the CSV program at our Research Triangle Park site. You will set validation strategy, drive continuous improvement, and ensure data integrity across computerized systems throughout planning, testing, and retirement.

You will partner with QA, Manufacturing, Automation, and Facilities to ensure compliance with FDA/cGMP requirements and CSA testing approaches, supporting on-time system go-lives.