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Qualification Engineer (M/F/D)
EPM is currently representing internationally active biotech company based in the Berlin area.
The company focuses into biopharmaceutical production primarily for the Oncology indication.
Currently, they are looking for a qualification engineer to support their team through a growth phase in the Engineering department.
Your tasks are:
* Coordination and execution of project-specific qualification and validation activities according to GMP regulations
* Creation of test plans for the various qualification phases DQ, IQ, OQ and PQ as well as responsibility for the execution and supervision of the tests
* Interface between engineering and QA as well as external service partners
* Support of the commissioning and implementation phase of the qualification on site
* Coordination and independent execution of qualification activities
* Responsibility for deviation, CAPA and CCO management as well as follow-up and monitoring
* Representation of the activities in internal and external audits
Qualifications:
* Degree in biotechnology, pharmaceuticals, process engineering, medical technology, facility management & engineering or a similar course of study
* Knowledge in quality control or quality assurance according to GMP
* Proactive, quality-conscious and efficient way of working
* Very good knowledge of German and English
Qualification Engineer (M/F/D)
- Location Berlin
- Salary Negotiable
- Discipline Bioengineering & Medical Engineering
- Reference PR/398114_1669396412
EPM is currently representing internationally active biotech company based in the Berlin area.
The company focuses into biopharmaceutical production primarily for the Oncology indication.
Currently, they are looking for a qualification engineer to support their team through a growth phase in the Engineering department.
Your tasks are:
* Coordination and execution of project-specific qualification and validation activities according to GMP regulations
* Creation of test plans for the various qualification phases DQ, IQ, OQ and PQ as well as responsibility for the execution and supervision of the tests
* Interface between engineering and QA as well as external service partners
* Support of the commissioning and implementation phase of the qualification on site
* Coordination and independent execution of qualification activities
* Responsibility for deviation, CAPA and CCO management as well as follow-up and monitoring
* Representation of the activities in internal and external audits
Qualifications:
* Degree in biotechnology, pharmaceuticals, process engineering, medical technology, facility management & engineering or a similar course of study
* Knowledge in quality control or quality assurance according to GMP
* Proactive, quality-conscious and efficient way of working
* Very good knowledge of German and English