Prozessingenieur (m/w/d) Pharma - Specialist Validation with university degree and a minimum of 3 years experience in validation and qualification
3500 Krems an der Donau Vollzeit
Our client is an international company in pharma industry, located in Krems an der Donau.
We are searching for a fulltime Specialist Validation.
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
k.prilisauer@powerserv.at