Process Expert II (m/f/d)

About the role

As a Process Expert II you will be at the forefront of controlling and maintaining environmental conditions in cleanroom environments for the manufacture of biological medicines. You will plan, oversee and trend environmental monitoring and cleaning activities, investigate deviations and continuously optimise processes to ensure safe, compliant production.

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 parameters, gowning, disinfection, sampling, aseptic techniques, cleanroom cleaning and validation, and autoclave validation.
• Coordinate manufacturing activities to meet GMP documentation and timelines.
• Monitor sampling results, identify trends, take corrective actions and prepare periodic monitoring reports.
• Lead deviation investigations and collaborate with cross‑functional experts.
• Manage validations, re‑validations, qualifications and annual process reviews in line with regulations.
• Implement and maintain site quality systems and support new process standards.
• Perform risk and gap assessments and evaluate corrective actions.
• Ensure inspection readiness and support internal and external audits.

Required profile

• University degree in Microbiology, Biotechnology, Biology, Pharmacy or a related scientific discipline.
• Proficiency in English and Slovenian.
• Good working knowledge of Microsoft Office tools.
• Excellent communication skills with ability to work independently, make decisions and prioritize tasks.
• Interest in digitalisation, process automation and AI applications.

Required skills

• Microsoft Office
• Good Manufacturing Practice (GMP) knowledge
• Microbiology expertise

What we offer

• Competitive salary with annual bonus.
• Flexible working schedule and hybrid remote options.
• Pension scheme and optional collective health insurance.
• Employee recognition and well‑being programs.
• Unlimited learning and development opportunities.