Computer System Validation Engineer

Katalyst CRO; Bothell (WA); Presencial; USD 90.000 - 135.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Bothell, WA, seeks a Computer System Validation (CSV) Engineer to lead validation activities for GxP electronic systems, especially MES, coordinating with Business Owners, Technical Owners, and Quality teams.

You will author and review CSV documentation, develop requirements, ensure SDLC and 21 CFR Part 11 compliance, and maintain Validation Plans, IQ/OQ/PQ, Trace Matrices, and SOPs across the validation lifecycle.

Formación

• Bachelor's degree required in Life Sciences, Engineering, IT, or related field.
• Minimum 4+ years direct CSV experience in regulated environments.
• Strong knowledge of GAMP and risk-based validation.
• Understanding of electronic records and electronic signatures.
• Solid MES validation experience.
• Familiarity with MES such as Emerson Syncade, SAP/Oracle, and InfoBatch.
• Experience developing CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Reports, Trace Matrices, SOPs).

Responsabilidades

• Author, review, and approve CSV documentation.
• Lead and execute validation activities for GxP electronic systems.
• Partner with Business Owners, Technical Owners, and Quality teams.
• Develop requirements and specifications for computerized systems.
• Support MES validation activities.
• Maintain CSV documentation across the validation lifecycle.
• Ensure compliance with cGMP, GxP, GAMP, 21 CFR Part 11 and Good Documentation Practices.
• Utilize IT service management platforms for incident/problem/change management.

Conocimientos

GAMP knowledge

Risk-based validation

Electronic records & signatures

MES validation

GxP compliance

Educación

Bachelor's degree in Life Sciences, Engineering, IT, or related

Herramientas

ServiceNow

InfoBatch

Emerson Syncade

SAP

Oracle

Descripción del empleo

Job Summary

• We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
• The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.
• The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.
• Author, review, and/or approve applicable CSV documentation.
• Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
• Assist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.
• Support validation activities for Manufacturing Execution Systems (MES).
• Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
• Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
• Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
• Utilize IT service management platforms to support incident, problem, and change management activities.
• Work with Business Quality Management Systems and related validation processes.

Roles & Responsibilities

• Author, review, and/or approve applicable CSV documentation.
• Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
• Assist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.
• Support validation activities for Manufacturing Execution Systems (MES).
• Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
• Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
• Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
• Utilize IT service management platforms to support incident, problem, and change management activities.
• Work with Business Quality Management Systems and related validation processes.

Education & Experience

• Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.
• Minimum 4+ years of direct experience in Computer System Validation (CSV).
• Strong knowledge of GAMP and risk-based validation approaches.
• Good understanding of electronic records and electronic signatures.
• Strong knowledge of Manufacturing Execution System (MES) validation.
• Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.
• Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
• Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.
• Experience with IT service management platforms such as ServiceNow.
• Exposure to Business Quality Management Systems such as Veeva.