CSV & Validation Program Manager | GMP Software Systems

Kriya Therapeutics, Inc.; Morrisville (NC); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Time Off & Work-Life Balance

Health & Wellness

Financial Security

Job summary

Kriya Therapeutics, Inc. is seeking a Manager for Computer Software Assurance & Validation to lead our CSV program at the Research Triangle Park site.

You will define validation strategy, drive improvements, and ensure data integrity across computerized systems in a GMP environment. Ideal candidates have 7+ years of CSV experience in biopharma, strong knowledge of FDA regulations and GAMP 5, and the ability to guide cross-functional teams through validation lifecycle stages from planning to

Qualifications

• Minimum bachelor’s degree in engineering or life science related field.
• Minimum seven (7) years of CSV experience in cGMP pharmaceutical or biopharmaceutical environments.
• Deep knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820), GAMP 5, and risk-based computer software assurance.
• Experience validating domain- and process-controlled systems, building monitoring/alarm systems, historians, and test automation tools/frameworks.
• Strong knowledge of data integrity practices, including MHRA and PIC/S guidance.

Responsibilities

• Lead the Computer System Validation (CSV) program, including lead and manage continuous improvement efforts for the CSV program.
• Implement risk-based computer system validation approach/methodologies based on GAMP 5, including critical thinking and computer software assurance (CSA) approach.
• Provide oversight for the CSV program; provide input to, author, revise in creation, support and maintenance of SOPs, work instructions or forms.
• Represent CSV on projects/initiatives, and provide input into the planning, development, and implementation of computer systems validation documentation.
• Oversee the development of validation documentation (e.g., System Impact Assessment, User Requirements Specification, Validation Plan, Risk Assessment, Test Protocols, and other deliverables) according to CSV procedures and following the CSA approach regarding testing.
• Review and audit of computer system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
• Ensure the execution of data integrity assessments, including resolution/mitigation of gaps identified through validation testing or procedural controls.
• Partner with Business Owners and Quality to ensure data integrity controls are effective and compliant.
• Review and approve change control activities for computerized systems.
• Own and maintain the computerized system inventory.
• Provide CSV oversight for manufacturing-related systems, including domain and process-controlled systems, building monitoring and alarm systems, and process historians.
• Partner with Automation, Manufacturing, and Facilities to validate computerized systems supporting GMP production, utilities, and building management.
• Ensure manufacturing systems maintain a validated state across implementation, change control, periodic review, and retirement.
• Review and approve periodic review activities for computerized systems.
• Provide leadership and guidance to and collaborative with cross-functional teams to accomplish company objectives and team goals to support on-time completion of system go-lives and enhancements.
• Oversee creation/authoring of standard operating procedures, policies, and validation master plan on an as-needed basis as it relates to the CSV program.
• Oversee contract validation support.

Skills

CSV leadership

Regulatory compliance

GAMP 5

Documentation writing

Cross-functional collaboration

Education

Bachelor’s degree in engineering or life science field

Tools

CSA tools

Test automation tools/frameworks

Regulatory systems

Job description

Kriya Therapeutics, Inc. is seeking a Manager for Computer Software Assurance & Validation to lead our CSV program at the Research Triangle Park site.

You will define validation strategy, drive improvements, and ensure data integrity across computerized systems in a GMP environment. Ideal candidates have 7+ years of CSV experience in biopharma, strong knowledge of FDA regulations and GAMP 5, and the ability to guide cross-functional teams through validation lifecycle stages from planning to