MES Operations Analyst – Mid West

MES Operations Analyst – Mid West

Recruiters Comments:

Job Description:

Do you enjoy a friendly and collaborative culture, where great ideas are not just encouraged but are rewarded?
One of the most dynamic companies in Mid West is looking for a MES Operations Analyst to be a member of their fantastic team.
If you would like to work in a company where:
  • “Employees feel good about the ways they contribute to the community.”
  • “Employees are proud to tell others they work here.”
  • “you join the company, you are made to feel welcome
  • “Management is honest and ethical in its business practices.”
  • “People celebrate special events around here.”
If you’re passionate about your work and would you like to progress your career in a fast-paced, challenging, yet ultimately but rewarding environment then this could be the next step in your career.
In this role, you’ll be responsible for the Design and Configuration of the Manufacturing Execution Systems (MES) manufacturing Batch Records and Equipment data and also for eliciting and documenting manufacturing business processes requirements.

The role:

  • Design and deploy a MES system (Werum’s PAS-X)to replace the paper-based process or manual processes in the processing areas
  • Coordinates the needs of functional departments and establishes priorities for MES User requirements gathering, system design and implementation
  • Actively participate in project deliverables such as Review of company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess requirements for designing electronic records
  • Design and develop MES recipes, workflows, Equipment, Master Data and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QA
  • Participates in the Creation and Testing of MES related protocols
  • Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle
  • Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state
  • Liaise with Technical Trainers to develop training plans for MES users
  • Provides end-user support for the MES including troubleshooting problems on the floor and work closely with IT to troubleshoot problems
  • Implement strategies to improve process efficiencies



Knowledge and Skills:

  • Knowledge of Biopharma Manufacturing and Supply Chain Process
  • Knowledge and experience of MES preferably Werum PAS/X
  • In-depth knowledge of concepts of GMP, ICC guidelines and GAMP requirements
  • An understanding of the project lifecycle and of quality management processes
  • Logical troubleshooting and problem-solving skills
  • Excellent analytical, written and oral communication skills
  • BS/BA/BEng in a Technical Discipline required, with 0-2 years of experience working within a Life Sciences manufacturing environment. Will substitute relevant industry experience in lieu of the educational requirement



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Salary: Permanent role
Recruitment Contact

Contact: Emilia

Telephone: 061 209 519


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