Computer System Validation Engineer

Katalyst CRO; Bothell (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead validation activities for GxP computerized systems, with a strong focus on MES in a pharmaceutical setting.

The ideal candidate will manage CSV lifecycle activities, develop validation documents, and ensure compliance with GAMP, 21 CFR Part 11, and GDP while collaborating with QA, Manufacturing, IT, and business owners to deliver audit-ready systems.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or related discipline.
• 4+ years of CSV experience in a GxP-regulated pharmaceutical/biotech manufacturing environment.
• Strong MES validation experience (e.g., Emerson Syncade).
• Solid knowledge of CSV principles, validation lifecycle, and regulatory standards (GAMP, 21 CFR Part 11, GDP).

Responsibilities

• Lead and execute CSV activities across validation lifecycle for GxP systems and applications.
• Develop, review, execute, and maintain CSV documentation (IQ/OQ/PQ, URS, Validation Plans, SOPs).
• Support MES validation and ensure regulatory compliance.
• Collaborate with QA, Manufacturing, IT, and Business Owners to develop validation deliverables.

Skills

CSV lifecycle

GAMP 5

21 CFR Part 11

UAT

Technical writing

Education

Bachelor's degree in Life Sciences or related field

Tools

Emerson Syncade

SAP

Oracle

InfoBatch

Veeva

ServiceNow

Job description

Job Summary

• We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment.
• The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality requirements.

Roles & Responsibilities

• Lead and execute Computer System Validation (CSV) activities for GxP computerized systems and applications throughout the validation lifecycle.
• Develop, review, execute, and maintain CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, Validation Summary Reports, and SOPs.
• Support the validation of Manufacturing Execution Systems (MES) and ensure compliance with internal procedures and regulatory requirements.
• Partner with Business Owners, Technical Owners, Quality Assurance (QA), Manufacturing, Engineering, and IT teams to develop validation deliverables and system requirements.
• Assist with User Acceptance Testing (UAT) by supporting protocol execution, documenting test results, investigating test failures, and ensuring testing complies with established procedures.
• Develop system requirements and specifications for computerized systems used in GxP manufacturing operations.
• Perform risk-based validation activities in accordance with GAMP methodology.
• Ensure compliance with cGMP, GxP, GAMP, SDLC, and 21 CFR Part 11 regulations governing computerized systems and electronic records.
• Support change control, incident management, and system lifecycle activities using IT service management tools.
• Collaborate with cross-functional teams to resolve validation issues and maintain audit-ready documentation.
• Provide on-site support throughout User Acceptance Testing (UAT) execution.

Requirements / Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related discipline (or equivalent industry experience).
• 4+ years of experience in Computer System Validation (CSV) within a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
• Strong hands-on experience with Manufacturing Execution Systems (MES) validation (e.g., Emerson Syncade).
• Strong understanding of Computer System Validation (CSV) principles and validation lifecycle activities.
• Experience developing and executing CSV documentation, including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Functional/Design Specifications
  • Risk Assessments
  • IQ/OQ/PQ Protocols
  • Validation Summary Reports
  • Traceability Matrices
  • Standard Operating Procedures (SOPs)
• Strong knowledge of GAMP 5, 21 CFR Part 11, cGMP, GxP, SDLC, and Good Documentation Practices (GDP).
• Experience with User Acceptance Testing (UAT), protocol drafting, execution, and defect management.
• Familiarity with ERP systems (e.g., SAP, Oracle) and Electronic Batch Records (EBR) systems (e.g., InfoBatch).
• Experience with Quality Management Systems (e.g., Veeva) and IT Service Management tools (e.g., ServiceNow).
• Knowledge of pharmaceutical manufacturing, laboratory systems, and biologics manufacturing processes.
• Excellent technical writing, communication, problem-solving, and cross-functional collaboration skills.
• Ability to work independently while managing multiple validation activities in a fast-paced, regulated environment.