Senior CSV Engineer

We are seeking an experienced Senior CSV Engineer to support a major pharmaceutical manufacturing and capital project environment. The successful candidate will take a lead role in the validation and compliance of computerised systems, ensuring systems are implemented and maintained in accordance with GMP, GAMP 5, data integrity requirements, and applicable regulatory standards.

This is a senior-level position suited to a CSV professional with strong experience working within pharmaceutical, biotechnology, or other highly regulated manufacturing environments.

Key Responsibilities

• Lead and execute Computer System Validation (CSV) activities across manufacturing, laboratory, automation, engineering, and business systems.
  

• Develop, review, and approve validation documentation including:
  

  • Validation Plans
    

  • User Requirements Specifications (URS)
    

  • Functional and Design Specifications
    

  • Risk Assessments
    

  • Configuration Specifications
    

  • IQ/OQ/PQ protocols
    

  • Traceability Matrices
    

  • Validation Summary Reports
    

• Apply a risk-based validation approach in accordance with GAMP 5 and site procedures.
  

• Ensure computerised systems comply with applicable GMP, data integrity, electronic records and electronic signature requirements, including 21 CFR Part 11 and EU Annex 11 where applicable.
  

• Work closely with Engineering, Automation, IT, Quality, Operations, Laboratory and equipment vendors throughout the system lifecycle.
  

• Review system architecture, configurations, software functionality, interfaces and data flows from a validation and compliance perspective.
  

• Support the validation of systems such as DCS, PLC/SCADA, MES, historian, laboratory, utility, manufacturing and other GxP computerised systems.
  

• Lead or support execution of validation testing, deviation resolution and defect management.
  

• Perform and document GxP system risk assessments and determine appropriate validation controls.
  

• Support commissioning and qualification activities where computerised systems interface with process equipment.
  

• Manage validation deliverables from third-party vendors and system integrators.
  

• Support change controls, deviations, CAPAs, periodic reviews and system lifecycle activities.
  

• Participate in regulatory inspections, internal audits and quality reviews as the CSV subject matter expert.
  

• Provide technical guidance and mentoring to junior CSV or validation engineers.
  

• Drive continuous improvement in CSV processes, templates and validation methodologies while maintaining regulatory compliance.
  

Experience & Qualifications

• Degree in Engineering, Computer Science, Automation, Science, Information Technology or a related technical discipline.
  

• Typically 5–8+ years' experience in Computer System Validation, preferably within pharmaceutical, biotechnology or regulated manufacturing.
  

• Strong working knowledge of GAMP 5 and risk-based computer system validation.
  

• Good understanding of EU GMP Annex 11, 21 CFR Part 11 and data integrity principles such as ALCOA+.
  

• Demonstrated experience generating and executing CSV lifecycle documentation.
  

• Experience with GxP manufacturing or laboratory computerised systems.
  

• Strong understanding of validation lifecycle management, change control, deviation management and quality systems.
  

• Experience working with automation platforms, manufacturing systems or laboratory systems would be highly advantageous.
  

• Ability to review technical documentation and translate regulatory requirements into practical validation strategies.
  

• Strong stakeholder management and communication skills, with the ability to work effectively across Quality, Engineering, Automation, IT and Operations teams.
  

• Comfortable operating independently and taking ownership of validation workstreams within complex projects.
  

Desirable Experience

Experience in one or more of the following would be advantageous:

• DeltaV or other DCS platforms
  

• PLC / SCADA systems
  

• MES
  

• OSIsoft PI / process historians
  

• LIMS or laboratory systems
  

• Building Management Systems (BMS)
  

• Environmental Monitoring Systems
  

• Serialization or packaging systems
  

• ERP / SAP systems
  

• Data integrity assessments
  

• Automation or equipment qualification
  

• Pharmaceutical capital projects, facility expansions or technology transfer projects
  

The Role

This position offers the opportunity to work on technically complex pharmaceutical manufacturing and digital systems projects within a highly regulated GMP environment. The Senior CSV Engineer will have significant responsibility for validation strategy, execution and compliance, while working alongside multidisciplinary engineering, automation, quality and manufacturing teams.