Automation CSV Engineer, Cork, Ireland
- Experience Level
- Experienced (non-manager)
Automation CSV Engineer – Cork - Ireland
Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.
Operating across 5 continents and with over 850 skilled employees, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimisation and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We’re looking for dedicated, innovative and driven talent to join our expanding team.
“Innovation and change, Join ZT”
About the role:
Zenith Technologies are looking to hire a CSV Engineer to join the Managed Services Team with one of our Global Pharmaceutical Clients. The CSV Engineer will work as part of the Execution Systems team.
- Global and Site Change Control Impact Assessments
- Automation Change (CQC) Review and Approval
- CSV Deliverables including 21CFR11 Assessments, Annex 11 Assessments, Business Criticality Assessments, GAMP Assessments
- Review and Approval of Automation Designs
- SMTS pre-approval, review and post approval prior to progression to IOQ
- Installation and Operation Qualification Protocol Generation, Execution and Reporting for DeltaV (PAS), PLCs, QBAS, MES, NQBAS
- Maintenance, Review and Approval of site Quality documentation e.g. SLIA, CLIA, System Descriptions, CSV Inventory List
- Yearly commitments made to develop and complete continuous improvements as part of the validation team
- Co-ordination of changes to ensure timely delivery
- Take ownership of project deliverables and manage these to completion
- A BSc/BEng/BA Degree or equivalent experience with advanced degree.
- Experience working within a regulated environment.
- Computer Systems Validation experience
- Strong problem-solving skills and an ability to analyze scenarios to develop the most appropriate solution are required.
- Ability and flexibility to perform all other job-related and ad-hoc duties as required.
- Attention to detail, flexible/adaptable, good communication, GDP, ability to work on own initiative,
- Good technical understanding of automation systems (DeltaV, Siemens & Allen Bradley PLCs)
- Good technical understanding of MES Systems (Werun Pas-X) and Data Historians (Osi Pi).
- Strong knowledge of Annex 11 and 21CFR Part 11.
- Completion of certified data integrity training very desirable but not essential.
More searches like this
- Information Technology Unavailable - GBP Full Time Permanent jobs in Ireland
- Programming Unavailable - GBP Full Time Permanent jobs in Ireland
- Manufacturing Unavailable - GBP Full Time Permanent jobs in Ireland
- Engineering Unavailable - GBP Full Time Permanent jobs in Ireland
- Validation Unavailable - GBP Full Time Permanent jobs in Ireland