Job description :

In this role, you will assume overall technical responsibility for selected equipment and systems used in the production and packaging of sterile pharmaceuticals. You will work closely with production, bridging the gap between operations and technology, and driving technical improvements directly within ongoing operations as well as through projects closely linked to the business.

Your tasks in detail

• Technical support and continuous development of manufacturing, production, filling and packaging systems for sterile pharmaceuticals
• Ensuring high plant availability while strictly adhering to GMP, hygiene and quality requirements.
• Independent planning and implementation of business-related technical projects, e.g.:
  • Performance and availability optimizations
  • Conversions and retrofits of existing systems
  • technical improvements resulting from deviations, trends, and audits
• Technical responsibility for maintenance, repair and optimization measures , including coordination of internal and external resources.
• Supporting production in case of disruptions, deviations and troubleshooting
• Active participation in government and customer audits as a technical contact person
• Professional evaluation and collaboration within the framework of:
  • Qualification and requalification measures (IQ/OQ/PQ)
  • Technical changes, deviations and CAPAs
  • Risk analysis (e.g. FMEA)
• Close, collaborative partnership with production, quality assurance, MS&T and other engineering interfaces

Ideally, you should bring the following:

• Successfully completed studies in process engineering, pharmaceutical engineering, mechanical engineering, chemical engineering or a comparable field
• ; alternatively: technician with relevant experience in sterile pharmaceutical production
• Several years of relevant professional experience in the pharmaceutical industry, ideally in a sterile/aseptic environment
• Solid GMP knowledge and practical experience in qualification, change management and technical documentation
• Strong interest in operational issues and pragmatic implementation of technical solutions
• Structured, analytical and independent work style with a high quality awareness
• Strong communication and interface skills in the production environment
• Very good German skills and good English skills, both spoken and written.

Additional information:

Target classification E11 - Technical (gross salary 5,183.00 € - 6,645.00 €)