CSV Engineer
CSV Engineer
Posted on :
10-07-2025
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1 Vacancy
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Job Description
Horizon Controls Group are hiring for a CSV Engineer to assist with one of client sites.
What you will be responsible for:
Reporting to the Project Manager and CSV Lead specifically responsible for Computer System Validation.
The CSV engineer will be responsible for the development of key quality documents such as Quality Assurance (QAPs) test plans Requirements Traceability Matrices and Quality assurance summary reports ensuring adherence to MSD and regulatory standards.
Will be required to work closely with teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
Will review and ensure vendors compliance with quality standards.
Will represent the CSV function at Automation IT and other project meetings as required.
Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital projects as defined by the CSV lead.
Develop and maintain Qualification Plans and Test Plans aligned with the overall project C&Q plan and with the leveraging strategy
Develop templates for all SDLC deliverables compliant with standards to ensure consistent implementation of the validation strategy including but not limited to: o Requirements Specification o Requirements Traceability Matrix o Functional Specification
o Design Specification
o Code Review
o Test specification/test script
Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met in all deliverables
Approval of all Digital MMD SDLC deliverables ensuring compliance with standards
Provide FAT oversight and perform leveraging assessments
Provide guidance and support to Digital team members tasked with delivery of SDLC documents
Provide input to the development of realistic project schedules and document trackers
Work closely with suppliers / integrators to ensure compliance with standards
Participate in and support relevant project meetings
Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to Digital validation requirements
Fluent in English written and verbal.
Minimum of 4 years experience in a similar role in life sciences ideally in pharmaceutical manufacturing.
Expert knowledge of GAMP5.
Experience in the following systems is essential; Emerson DeltaV
Experience in the following systems would be advantageous; DCS Siemens PLC/SCADA OSISoft PI Werum Pax-X
This is a site based role.
The successful candidate may sometimes be required to attend meetings at Vendor premises or other sites as required.
Excellent computer skills proficient in the use of the following Microsoft tools: Excel SharePoint Word and PowerPoint.
Strong interpersonal and communication skills (verbal and written).
Relevant Computer Science or Engineering degree or equivalent
Previous experience working with paperless validation systems (Kneat) will be advantageous.
Get in touch today or alternatively call George on
Employment Type
Full Time
Key Skills
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