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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Process Engineer - Pharmaproduktion

Full-TimeUpdated
No salary listed
Mid
Bachelor's
Halle, Germany
In PersonOn-site at the Halle/Westfalen production facility.
Biology & BiotechBioprocess & Biomanufacturing

About the job

Requirements
  • A completed degree in Pharmacy, Process Engineering or Pharmaceutical Engineering, Biotechnology, or Food Technology.
  • Pharmaceutical knowledge in aseptic manufacturing or professional experience in a pharmaceutical-technical production environment.
  • Willingness to develop detailed knowledge of processes, workflows, and technology.
  • Understanding of complex processes, communication skills, and willingness to learn.
  • Independent, structured, and analytical working style.
  • Very good spoken and written German and English.
Responsibilities
  • Ensure routine process workflows and safe operations (GMP and EHS), and continuously optimize processes on an assigned production line using key performance indicators while maintaining compliance with applicable regulations.
  • Adapt processes to new products in collaboration with internal departments.
  • Assess and document process stability through regular on-site presence (Gemba).
  • Monitor recertification processes, such as calibrations; conduct qualifications and support validation activities.
  • Statistically assess process stability, for example using Minitab, and standardize processes.
  • Process deviations and systematically analyze causes to continuously improve process stability.
  • Process notable findings, including defining and implementing corrective and preventive actions (CAPA).
  • Create and process change controls.
  • Create and revise documents such as work instructions, checklists, and other standard operating procedures in German and English.
  • Conduct personnel training.
  • Oversee external companies in production during training or process observations.
  • Coordinate and conduct test runs for new processes or after maintenance shutdowns.
  • Be responsible for aseptic process simulations.

About the company

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Simtra BioPharma Solutions

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Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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