Engineering Lead (m/w/d).

Job ID: 11137

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Discipline
Quality/Production
Type of employment
Project Consulting
Company
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
Responsibilities

Start-up phase of the Restart Fermtec:

  • Project Engineer (Process) in the project team for planning, erection, qualification and start-up of steps 1-7.
  • Responsible for different process units during all phases of the project.
  • Supervise the involved engineering contractor and suppliers (time, budget, quality).
  • Responsible for the technical documentation (GMP, HSE, etc.) in his field during all phases of the project.
  • Responsible for a successfully qualification and start-up of different process units.
  • Know how transfer.
  • Reporting to the lead engineer and the project director of the project team

 

Commercial operation after PPQ:

  • Ensures constant technical availability of production equipment
  • Maintaining of all process equipment and instrumentation according to GMP, HSE and economic requirements during operation
  • Conducts preplanning including cost estimates of capital projects
  • Develops ideas together with plant team relating to process, building, zoning, safety, quality and time schedules
  • Sets up, leads and coordinates maintenance activities
  • Develops ideas together with plant management team relating to process, building, zoning, safety, quality and time schedules
  • Prepares specifications/tender documents for all maintenance activities
  • Prepares the SPE documentation and manages the approval process
  • Supervising the maintenance contractors and suppliers (time, budget, quality) to ensure technical system availability.
  • Planning of preventive maintenance actions
  • Monitoring of energy consumption and energy costs
  • 'Qualified person' (Sachkundiger) in respect to the German “Betriebssicherheitsverordnung” (BSV) to exercise testing activities
Requirements
  • Process engineer or adequate education
  • Specific biotechnological technical know how (e.g. sterile technology)
  • German (native in speaking and writing)
  • English (good in reading, writing and speaking)
  • 5 years experience in process technology
  • 3 years experience in pharmaceutical production
  • Computer skills in MS-office and SAP
  • Essential behavioural competences
  • Team player with good/excellent communication skills
  • Convincing behaviour
  • Independent and systematic working method
Region
Mitte