CSV Engineer

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.