Process Expert II – Environmental Control
novartis · Mengeš
Job description
About the role
Join Novartis as a Process Expert II responsible for controlling and maintaining environmental conditions in cleanroom environments. You will plan, oversee, and optimise environmental monitoring and cleaning activities to ensure safe, compliant manufacturing of biological medicines.
Key responsibilities
- Provide expert support for establishing, maintaining, and controlling environmental conditions in pharmaceutical manufacturing.
- Act as Subject Matter Expert for microbiological and physical environmental conditions, gowning, disinfection, sampling, cleanroom cleaning, and autoclave validation.
- Coordinate timely completion of manufacturing activities in line with GMP documentation.
- Monitor sampling results, identify trends, prepare periodic reports, and take corrective actions.
- Lead deviation investigations and manage validations, re‑validations, and annual process reviews.
- Implement and maintain site quality systems and assess risk, gaps, and corrective actions.
Required profile
- University degree in Microbiology, Biotechnology, Biology, Pharmacy or a related scientific discipline.
- Proficiency in English and Slovenian.
- Strong communication skills, ability to work independently and prioritize tasks.
- Interest in digitalisation, process automation and AI applications.
Required skills
- Microbiology
- Good Manufacturing Practice (GMP)
- Microsoft Office
- Environmental monitoring techniques
- Cleanroom cleaning and validation
What we offer
- Competitive salary with annual bonus.
- Flexible working schedule and possibility to work from home.
- Pension scheme and collective health insurance options.
- Employee recognition and health promotion programmes.
- 12‑month fixed‑term contract.
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Published 4 hours ago
Expires 1 month from now
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novartis
Mengeš
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