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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”
* Engineering services and coordination of requirements and changes.
* Batch Record Design and Configuration of the Werum PASX System.
* Dry run of batch records.
* Master Data Updates.
* Initiate and support appropriate change management documentation.
* Operations Support for shakedown, engineering runs, UAT testing.
* Addressing feedback and comments from operations and other support functions on batch record design and modifications as needed up until GMP release for use in PPQ.
* Integration of batch records with ERP, PCS, and Data Historian at the site.
* Routing and approving batch records for approval and release in Werum PAS-X.
* Participate in on call support rotation for night and weekend support for approximately 1 week per month.
* Support revision and improvements to Batch records to ensure multi-product operation.
* Implement fixes/patches related to addressing open deviations and Corrective and Preventive Actions (CAPAs).
* Implement changes/fixes to support GXP, and GDPR (as applicable) compliance requirements.
* Suitability degree qualified engineer with at least 3 years’ experience of Werum PAS-X in a pharmaceutical/biopharmaceutical environment.
* Minimum 3 years’ experience supporting IT applications e.g. troubleshooting, managing incidents and change controls, design documentation, test case development, system & integration testing
* Experience of developing master batch records (MBRs) to reflect the manufacturing process and master recipes.
* Experience of weigh & dispense functionality, EBR functionality, e-log books etc.
* The successful candidate must be a highly motivated individual who is delivery focused and has experience of working successfully across multiple business & functional teams
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