CSV Engineer – MES

Role Overview

The CSV Engineer collaborates closely with Automation IT Quality Assurance Manufacturing and Engineering teams to deliver validation activities across system implementation upgrades and continuous improvement initiatives.

Key Responsibilities

Computer System Validation

• Execute the full Computer System Validation lifecycle in accordance with regulatory requirements and industry best practices (e.g. GAMP 5 FDA 21 CFR Part 11 EU Annex 11).
  

• Develop and maintain validation documentation including:
  

  • Validation Plans
    

  • User Requirement Specifications (URS)
    

  • Functional Specifications (FS)
    

  • Risk Assessments
    

  • Installation Qualification (IQ)
    

  • Operational Qualification (OQ)
    

  • Performance Qualification (PQ)
    

  • Traceability Matrices
    

• Support system change controls periodic reviews and revalidation activities.
  

MES Implementation & Support

• Participate in the implementation configuration and validation of Manufacturing Execution Systems (MES) such as:
  

  • Werum PAS-X
    

  • Syncade
    

  • Siemens Opcenter Execution Pharma
    

• Ensure MES solutions meet regulatory and operational requirements.
  

• Support recipe configuration electronic batch records (EBR) and system integration with other platforms (ERP LIMS automation systems).
  

• Assist with MES troubleshooting and system improvements.
  

Compliance & Quality Assurance

• Ensure all systems meet global regulatory requirements including FDA EMA and GMP guidelines.
  

• Participate in internal and external audits related to computerised systems validation.
  

• Maintain validation documentation in accordance with site quality systems.
  

• Ensure data integrity principles are applied across computerised systems.
  

Project & Stakeholder Support

• Work closely with automation engineers IT teams system integrators and quality teams during project execution.
  

• Support new system implementations upgrades and migrations.
  

• Provide CSV support during system FAT SAT and commissioning activities.
  

• Contribute to project planning and validation strategies for new digital manufacturing initiatives.
  

Documentation & Continuous Improvement

• Maintain validation documentation and ensure version control.
  

• Support continuous improvement initiatives for validation processes and digital systems.
  

• Assist in the development of validation templates and standards across the organization.
  

Requirements

Education

• Bachelors degree in Engineering Computer Science Information Systems or related technical discipline.
  

Experience

• 36 years of experience in Computer System Validation within the pharmaceutical biotech or life sciences industry.
  

• Experience validating Manufacturing Execution Systems (MES).
  

• Strong knowledge of GMP environments and validation standards.
  

• Experience with electronic batch records (EBR) and digital manufacturing solutions.
  

Technical Skills

• Computer System Validation (CSV) lifecycle management
  

• Manufacturing Execution Systems (MES)
  

• Electronic Batch Records (EBR)
  

• Risk-based validation approach
  

• Change control and deviation management
  

• System integration (MES ERP LIMS automation systems)
  

Regulatory & Industry Knowledge

• FDA 21 CFR Part 11
  

• EU Annex 11
  

• GAMP 5
  

• GMP and Data Integrity standards