Place of work:

Salary offered (gross):
From 1.200,- € – based on experience. Base salary is depending on seniority level and previous experience of candidate.

Contract type:

Start date:

Job Description

Position is supposed to cover validation of  manufacturing  processes in manufacturing units to be performed on time and in compliance with standards.

This is one of the key positions for realizing the first production and products of good quality and to the specification within defined frame of set ups.

Key duties and responsibilities:

  • Validation of  new production processes (except IQ) covering packaging, extrusion, catheter assembly process and if there are some additional process in the manufacturing unit in entire scope or partial scope as decided by agreement, however all processes have to be covered
  • Cooperation with all others department to ensure smooth validation process in order to be aligned with time plan and regulations
  • Re-validation of the processes as per time plan
  • Validation of processes required to be validated as result of operational project
  • Ensure availability of all necessary procedures, instructions, and forms according the rules and requirements and their compliance through validation/revalidation of the processes in manufacturing unit
  • Author for Validation Protocols and Reports
  • Updating and creating machine cards
  • To conduct/support a process investigation, to recognize the  inputs and outputs to the process by using a structured approach and tools such as process map, risk assessments, e.g. FMEA, Ishikawa diagram, flow charts
  • To process and understand statistical data
  • Providing regular updates to relevant manager
  • Providing validation and process knowledge & expertise if required


  • Relevant work experience as process or technology engineer or quality engineer – preferred
  • Knowledge and experience in operations, manufacturing engineering especially in medical devices industry is a big advantage
  • Experience in process validation and capability – preferred


  • Masters or advanced degree preferred in Technical / Engineering or Quality Management
  • Root cause analyze tools – advantage
  • Must be proficient with PC programs i.e. Office (Excel, Word, and PowerPoint) – mandatory , Basic Statistical tools, Minitab or Jump, SAP knowledge (advantage)
  • Minitab software, statistical techniques knowledge – preferred
  • Communicative level of English language
  • The position is suitable also for a fresh graduate


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