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Computer System Validation Engineer

Katalyst Healthcares & Life Sciences

Raleigh, NC

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Business Solutions, Change Management, Clinical Support, Computer Skills, Computer Systems, Cross-Functional, Delivery Management, Documentation, Documentation Plan, Drug Manufacturing, ERP (Enterprise Resource Planning), GxP, IT Service Management (ITSM), Information Technology & Information Systems, Laboratory Systems, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Systems, Oracle, Process Validation, Quality Management, Regulatory Requirements, Requirements Management, Requirements Validation/Verification, Risk, SAP, ServiceNow, Standard Operating Procedures (SOP), System Validation, Systems Administration/Management, Systems Engineering, Test Scripts, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Raleigh, NC
POSTED
Today
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.
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.

About the Company

K

Katalyst Healthcares & Life Sciences

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