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.
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