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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Betriebsingenieur - In der Pharmaproduktion

Full-TimePosted on 10/19/2026
No salary listed
Mid
Bachelor's
Halle, Germany
In PersonWork at the Halle/Westfalen site.
Biology & BiotechBioprocess & Biomanufacturing

About the job

Requirements
  • A completed degree in pharmaceutical process engineering or mechanical engineering, or an equivalent qualification.
  • Two to three years of professional experience in operations engineering, preferably focused on pharmaceutical manufacturing.
  • Knowledge of pharmaceutical aseptic manufacturing is an advantage.
  • Understanding of complex processes.
  • Strong communication skills.
  • A hands-on, solution-oriented, and resilient working style.
  • Very good spoken and written German and English.
  • Good computer and software skills, particularly in enterprise resource planning systems and Microsoft Office.
Responsibilities
  • Ensure GMP- and EHS-compliant operation and maintenance of assigned production systems using a maintenance management system, including asset administration and creating or modifying maintenance plans and work orders.
  • Coordinate internal and external service providers and ensure optimal spare-parts availability.
  • Plan and adhere to the maintenance budget.
  • Systematically solve technical problems and analyze deviation root causes using Lean and Six Sigma tools.
  • Plan in detail and operationally implement technical system changes for expansions, new installations, or optimization, including change control.
  • Take responsibility for budgets, schedules, performance, and quality parameters for technical system changes.
  • Prepare GMP-compliant project and qualification documentation, including user requirements specifications, functional specifications, risk analyses, and design, installation, and operational qualification documentation.
  • Conduct qualification activities and implement technical corrective and preventive actions.
  • Support site-wide energy management by identifying, evaluating, and implementing energy-saving measures.
  • Conduct training and act as the technical contact for the department.
  • Provide technical operational support through on-call duty.
Desired Qualifications
  • Pharmaceutical knowledge in aseptic manufacturing.

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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