Required skills
Languages: German
Job description
Experienced Operations Engineer sought for an optimization project in a GMP-regulated manufacturing environment, focusing on solid dosage forms. The role involves analyzing technical issues, managing deviations, and optimizing processes and documentation.
Project overview
As part of an optimization project in a GMP-regulated production environment, an experienced operations engineer is sought to provide technical support for the manufacturing of solid dosage forms. The focus is on analyzing technical problems, handling deviations, and optimizing processes, documentation, and quality measures. The goal is to sustainably improve plant performance, GMP compliance, and process stability, as well as to technically and regulatorily support the commissioning of a new production plant.
Responsibilities
- Analysis of technical problems with production plants
- Execution of deviation and root cause analyses
- Development and evaluation of CAPA measures
- Support with change control processes and risk assessments
- GMP-compliant optimization of documentation, SOPs, and processes
Requirements
- Completed engineering degree or comparable qualification
- At least 5 years of professional experience in a GMP-regulated environment
- At least 3 years of experience in the manufacturing of solid dosage forms
- Sound knowledge of deviation management, CAPA, and EU-GMP regulations
- Structured, independent, and solution-oriented way of working
Project details
- Start: ab sofort
- Duration: 4 Monate
- Remote: onsite
- Location: München, Deutschland, DE
- Languages: German
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