Process Engineer

vor 1 Woche


BadenBaden, Baden-Württemberg, Deutschland gempex GmbH - THE GMP-EXPERT Vollzeit
About gempex GmbH - THE GMP-EXPERT

We are a leading expert in GMP (Good Manufacturing Practice) solutions, serving the Life Sciences industry with a passion for quality and excellence.

Job Description

Job Title: Process Engineer - Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Process Engineer - Quality Assurance Specialist to join our team in Mannheim. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our GMP projects.

Key Responsibilities:

  • Develop and implement GMP-compliant documentation, including Standard Operating Procedures (SOPs) and risk analyses, in both German and English.
  • Qualify pharmaceutical production equipment and facilities.
  • Conduct requalifications and periodic reviews in accordance with the Life Cycle.
  • Coordinate qualification, calibration, and maintenance activities.
  • Review technical documents and drawings.
  • Manage changes and deviations, including change control and quality assurance measures.

Requirements:

  • Bachelor's degree in Process Engineering, Pharmaceutical Technology, Biotechnology, Chemical Engineering, Life Sciences Engineering, or a related field.
  • Technical knowledge and ability to quickly adapt to various tasks.
  • 1-2 years of experience in the GMP field or pharmaceutical industry.
  • Independent and solution-oriented work style with a passion for teamwork.
  • Travel readiness for qualification activities at production sites, valid driver's license (Class B).
  • Excellent German and good English language skills.

What We Offer:

  • Broad insight into various customer projects from the Biotech/Pharma industry.
  • Flexible work and time models in a 30-day annual leave and unlimited contract model.
  • Opportunities for professional development, a comprehensive GMP training concept, a mentorship model, and exciting GMP projects in quality assurance.
  • A collegial and open company culture with short decision-making paths and a flat hierarchy.
  • Social benefits, including occupational pension provision, wealth-related benefits, and additional health insurance.
  • Bike leasing and company events.


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