Prozessingenieur (m/w/d) Pharma - Specialist Validation with university degree and a minimum of 3 years experience in validation and qualification
Einsatzort
3500 Krems an der Donau
Arbeitszeit
38 Std/Woche
Entgelt
ab 3395,16 EUR/Monat
Our client is an international company in pharma industry, located in Krems an der Donau.
Key activities & responsibilities
* Leading assigned Qualification and Validation activities
* Preparation of qualification plans, protocols, reports and procedures based on internal and external rules and standards
* Planning and execution of equipment and system qualifications as well as cleaning and process validation in cooperation with equipment/process owners (IPTs), contractors, and suppliers
* Perform/participate cycle development, qualification and re-qualification of sterilization processes (thermal, chemical, other physical methods)
* Participation and moderation of risk analysis of equipment, systems, and processes
* Planning and execution of Computerized Systems Validation (CSV) in corporation with IT and Process Automation
* Supporting improvement projects and problem solving for qualification and validation activities
* Support for change, deviation, and CAPA management
* Responsible for being compliant with safety guidelines and being capable of recognizing unsafe situations and acting safely on the job
Qualification
* Degree in Biotechnology, Process Engineering, Biochemistry, Microbiology, or similar disciplines
* Valdiation and qualificational background (min 3-5 years)
* Technological understanding for blend processes
* Experience in pharmaceutical environment with GMP-requirements
* Knowledge in qualification (IQ and OQ)
* Experienced working in an interdisciplinariy project team
* Excellent English skills and basic German skills
* Practical knowledge in Ellab equipment handling (would be a plus)
* Knowledge of Execute SIP PQ activities (would be a plus)
* Willingness to travel occasionally
We offer
* Full-time position 38h
* Home Office days agreeable
* The chance to work for an international group
Der für diese Position vorgesehene Brutto-Mindestverdienst beträgt EUR 3395,16 pro Monat. Bei entsprechender Qualifikation oder Berufserfahrung ist eine Überzahlung möglich.
Ihr Job-Kontakt:
Powerserv Austria GmbH
Katrin Prilisauer
Favoritenstraße 80
1100 Wien
+43 5 9007 1112
#J-18808-Ljbffr