MES Engineer – ref. MQ142

  • Contract
  • Carlow

Website HeadcountGroup Headcount Solutions

Headcount Solutions is sourcing a MES Engineer for our multinational client’s biologics facility. Reporting to the MES Lead, the MES Engineer will have responsible for supporting the delivery of an expansion to existing MES system (Werum PasX).

Main Responsibilities:

  • Participate in the development of key Automation quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuing adherence to all Automation documentation.
  • 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 client standards, to ensure consistent implementation of the validation strategy, including but not limited to: Requirements Specification / Requirements Traceability Matrix / Functional Specification / Design Specification / Code Review / Test specification/test script
  • Work closely with the Quality function and ensure their requirements are met in all deliverables.
  • Generate and Execute SDLC deliverables, ensuring compliance with standards.
  • Provide FAT oversight and perform leveraging assessments.
  • Provide input to the development of realistic project schedules and document trackers.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to automation validation requirements.
  • Shift work maybe introduced and if so, you will be expected to work shift hours. Shift pattern will be open to change depending on business requirement.

Requirements:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Fluent in English, written and verbal.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: MES Werum PasX OSI PI.

For further information please contact Mick directly of forward details in confidence below.

 

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