Lead CSV Engineer

Tipperary - Ireland

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 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

standardized 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 MSD 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

o Etc.

Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met

in all deliverables

Approval of all SDLC deliverables ensuring compliance with standards

Provide FAT oversight and perform leveraging assessments

Provide guidance and support to 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 MSD 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 validation requirements

Minimum of 3 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

Excellent computer skills proficient in the use of the following Microsoft tools: Excel SharePointWord 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 with George at if interested in this position.

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 QualityAssurance (QAPs) test plans Requirements Traceability Matrices and Quality assurance summaryreports...