Job World GmbH
1 week ago
Qualification Engineer for Pharmaceutical Industry (m/f/d)
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Company information
- Company
- Job World GmbH
- Location
- Österreich Austria
- Posted
- 1 week ago
Job description
JOB WORLD GmbH is a partner to leading pharmaceutical companies in Austria. We offer dedicated Qualification Engineers top access to interesting pharmaceutical jobs.
For a renowned pharmaceutical company, we are looking for a ***PERMANENT POSITION***
Qualification Engineer for Pharmaceutical Industry (m/f/d)
- Independent planning, control, and execution of qualification projects according to GMP (DQ, IC, OQ, PQ)
- Qualification of complex process plants; packaging plants, pure media and utility systems (e.g., PW/WFI, pure steam, compressed air, HVAC)
- Building automation and control systems
- Creation, review, and release of GMP-relevant documents (URS, risk analyses, qualification plans, reports)
- Technical and disciplinary leadership of qualification activities in new construction, renovation, and investment projects
- Evaluation of technical changes within the framework of change control procedures
- Processing and evaluation of deviations; OOS/OOT and CAPAs with a technical focus
- Close collaboration with QA, Engineering, Production, Automation, and external partners
- Technical support and coaching in the engineering environment
- Active participation in authority inspections, customer and supplier audits
- Ensuring GMP compliance of technical systems throughout their entire lifecycle
- Support in the development/optimization of a QMS system
- Completed vocational training (HTL, university degree) in engineering (process engineering, mechanical engineering, electrical engineering, automation technology), pharmaceutical technology, or comparable qualification
- Several years of professional experience in the pharmaceutical, biotechnology, or similarly regulated environment
- Solid knowledge of EU GMP regulations, especially Annex 1 and Annex 15
- Demonstrable experience in the qualification of complex plants and systems
- High quality awareness, structured and solution-oriented working method, assertiveness, communication skills, and sense of responsibility
- Very good German and good English skills, both written and spoken
- PERMANENT POSITION in a renowned pharmaceutical company in Upper Austria
- Very good remuneration starting from € 4,000.-- gross per month (higher pay possible with suitability and experience)
- A long-term position in an internationally successful pharmaceutical company
- A pleasant, open work environment in a dedicated team
- A thorough basic training process to prepare for the scope of tasks
- Numerous benefits such as discounted shopping opportunities, food vouchers, as well as various sports and health offers, and further training opportunities
- We are legally obliged to point out that the
ADZN1_AT
Required skills
- english
- german
- mechanical engineering
- production
- engineering
- risk analysis
- hvac
- process engineering
- audits
- automation
- electrical engineering
- reports
- gmp
- qa
- compressed air
- building automation
- pharmaceutical industry
- university degree
- qms
- biotechnology
- control systems
- quality awareness
- deviations
- change control
- automation technology
- annex 1
- annex 15
- capa
- pw
- upper austria
- ic
- pharmaceutical technology
- htl
- packaging plants
- dq
- urs
- pq
- eu gmp
- oq
- wfi
- process plants
- oos
- oot
- utility systems
- qualification engineer
- pure steam
- authority inspections
- qualification plans
- pure media systems
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