Jobs
My ads
My job alerts
Sign in
Find a job Employers
Find

Csv engineer

Recruitment by Aphex
Engineer
Posted: 12 December
Offer description

PurposeReporting to the Digital 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 Company and regulatory standards.* Will be required to work closely with Digital 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.Responsibilities* 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 Company standards, to ensure consistent implementation of the validation strategy, including but not limited to:o Requirements Specificationo Requirements Traceability Matrixo Functional Specificationo Design Specificationo Code Reviewo 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 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 Company 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 requirementsRequirments* Fluent in English, written and verbal.* 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, 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.

Apply
Create an E-mail Alert
Job alert activated
Saved
Save
Similar job
Executive engineer
Tipperary County Council
Engineer
Similar job
Senior devops engineer
Nenagh
Fiserv
Engineer
Similar job
Delta v engineer
Douglas Control and Automation
Engineer
Similar jobs
jobs County Tipperary
jobs Munster
Home > Jobs > Engineering jobs > Engineer jobs > Engineer jobs in County Tipperary > CSV Engineer

About Jobijoba

  • Company Reviews

Search for jobs

  • Jobs by Job Title
  • Jobs by Industry
  • Jobs by Company
  • Jobs by Location

Contact / Partnership

  • Contact
  • Publish your job offers on Jobijoba

Legal notice - Terms of Service - Privacy Policy - Manage my cookies - Accessibility: Not compliant

© 2025 Jobijoba - All Rights Reserved

Apply
Create an E-mail Alert
Job alert activated
Saved
Save