Manufacturing Execution System (MES) Engineer (w/m/d) 50%

For our client, Hoffmann La-Roche, we are looking for a motivated person for the temporary position Manufacturing Execution System (MES) Engineer (w/m/d) in Basel

With the MES team, we support production at Basel Biotech Manufacturing and Basel Small Molecule Manufacturing.
In addition to supporting ongoing production, the MES team is also responsible for the further development of MES systems. We see ourselves as a support unit to support production and upcoming projects with our know-how.

The perfect candidate

The requirement profile is characterized by a completed degree in computer science, electrical engineering, or a related field, as well as at least three years of professional experience as a System Engineer in the support of MES systems. Required is a deep understanding of IT architectures and Data Integrity coupled with sound knowledge of GMP, Compliance, as well as Computer System Validation (CSV). The profile is supplemented by confidence in creating risk analyses and validation documents, an independent, customer-oriented way of working, as well as business fluent German and good English.

General information:

• Start date:
• Planned duration of employment: 1 year
• Workplace: Basel
• Workload: 80-100%
• Home Office: temporarily possible

Tasks & Responsibilities:

• You are responsible for document management in the MES team, you create the respectively required documentation and ensure the up-to-dateness of SOPs and risk analyses.
• Together with the MES team, you ensure the administration and operation of the MES system. This also includes error analysis, problem solving, and on-call service.
• Together with our internal business partner, you analyze new requirements for the MES system and help with the implementation of an optimal solution.
• Collaboration and support in Change Control Management and qualification and/or validation activities according to Roche internal guidelines.

Must Haves:

• Completed degree in the field of computer science, electrical engineering or comparable
• At least 3 years of professional experience as a System Engineer and experience in the support of MES systems
• Broad understanding of Data Integrity requirements and IT architecture
• Sound knowledge regarding GMP, Compliance and Computer System Validation
• Experience and motivation for the creation of documents and risk analyses, as well as the topic of document management
• Very good German and good English skills are required
• Customer- and result-oriented, team player with very good communication and organizational skills
• Enthusiasm as well as an independent, customer-oriented way of working

Nice to Haves:

• Siemens Simatic IT MES knowledge / Siemens OpCenter Pharma MES knowledge
• Knowledge regarding automation systems (Siemens PCS7)
• PI / OsiSoft knowledge
• Experience in the support of MES systems for the automated manufacture of biotechnological products

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