Process Expert II – Environmental Monitoring & Cleanroom Validation

About the role

Novartis is looking for a Process Expert II in environmental conditions (m/f/d) in Mengeš, Slovenia. You will be at the forefront of controlling and maintaining environmental conditions in cleanrooms, ensuring safe and compliant manufacture of biological medicines. The position is offered on a 12-month fixed-term contract.

Key responsibilities

• Provide expert support in establishing, maintaining and controlling environmental conditions in pharmaceutical manufacturing.
• Act as a subject matter expert for microbiological and physical environmental conditions, gowning and disinfection, sampling and aseptic technique training, cleanroom cleaning and validation, and autoclave validation.
• Coordinate and complete manufacturing activities on time according to documentation and GMP.
• Monitor environmental sampling results, identify trends, act on adverse trends and prepare periodic reports.
• Lead deviation investigations and manage validations, revalidations and annual process reviews.
• Maintain site quality systems and support new process standards, perform risk and gap assessments, and ensure inspection readiness.

Required profile

• University degree in microbiology, biotechnology, biology, pharmacy or another relevant scientific field.
• Active knowledge of English and Slovenian.
• Excellent communication skills, independent work, decision-making and prioritisation.
• Interest in digitalisation, process automation and AI; knowledge of microbiology and GMP is desirable.

Required skills

• Good working knowledge of Microsoft Office.
• Knowledge of microbiological principles and GMP is desirable.

What we offer

• Salary range of EUR 22,050 to 40,950, with a possible short-term performance bonus.
• Flexible working arrangements, including the option to work from home.
• Pension scheme, collective health insurance option, employee recognition scheme and health promotion programmes.
• Learning and development opportunities, and where possible flexible or hybrid work.