Computer System Validation Engineer

Katalyst CRO; Raleigh (NC); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO seeks a CSV Engineer to lead validation activities for GxP electronic systems and MES across manufacturing and lab environments.

You will partner with Business and Technical Owners and QA to develop, review, and maintain CSV documentation in line with regulatory requirements.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, IT, or related field.
• Minimum 4+ years of direct CSV experience.
• Strong knowledge of GAMP and risk-based validation.
• Good understanding of electronic records and signatures.
• Strong MES validation experience.
• Familiar with MES like Emerson Syncade and ERP systems (SAP/Oracle).
• Experience developing CSV documentation (Plans, Requirements, Specs, Reports).
• Knowledge of biologics/clinical manufacturing environments.
• Experience with ITSM platforms (ServiceNow).
• Exposure to Veeva QMS.

Responsibilities

• Author, review, and approve CSV documentation.
• Lead validation activities for MES and cross-functional teams.
• Develop validation plans, requirements, specs, assessments, and test scripts.
• Ensure compliance with cGMP, GxP, GAMP, 21 CFR Part 11.
• Support testing, document failures, and align with internal procedures.
• Collaborate with Business/Technical Owners and Quality teams.

Skills

Bachelor's degree

CSV experience

GAMP

eSignature

MES validation

ERP systems

InfoBatch

CSV documentation

ServiceNow

Biologics knowledge

Education

Bachelor's degree in Life Sciences/Engineering/IT

Tools

InfoBatch

ServiceNow

ERP systems (SAP/Oracle)

Job description

Job Description

• 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.

Requirements

• 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.