About Your New Employer
A world leader in delivering digital transformation solutions to Life Sciences.
Operating across 5 continents and with over 850 skilled employees.
Single end to end partner for consultancy, design implementation, optimisation and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We are now looking for an MES Engineer with Werum Pas-X or Syncade to join a a world leader in delivering digital transformation solutions to Life Sciences on a permanent or contract basis.
About Your New Job
- Providing engineering services and coordinating requirements and changes.
- Designing batch records and configurating the Werum PASX System.
- Initiating and supporting appropriate change management documentation.
- Supporting operations 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.
- Integrating batch records with ERP, PCS, and Data Historian at the site.
- Routing and approving batch records for approval and release in Werum PAS-X.
- Participating in on call support rotation for night and weekend support for approximately 1 week per month.
- Implementing fixes/patches related to addressing open deviations and Corrective and Preventive Actions (CAPAs).
- Implementing changes/fixes to support GXP, and GDPR (as applicable) compliance requirements.
What Skills You Need
- Degree qualified engineer with at least 3+ years’ experience of Werum PAS-X or Syncade in a GMP environment.
- 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.
What’s on Offer
- Salary range varies with level of experience from 50k – 75k per annum
- Attractive hourly rates with minimum 12 months contract also available
- Hybrid working model - Cork or Dublin
- Healthcare + Pension + Bonus + 25 days' annual leave
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie
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