QA Operations Expert – Microbiology (d/f/m)

About the role

Sandoz is looking for a QA Operations Expert – Microbiology to act as the site Subject Matter Expert (SME) for microbiological and contamination control at its new manufacturing and quality control facility for Bioinjectable products in Brnik. The role suits an experienced quality professional who will help set up, shape and continuously improve the site's contamination control strategy, aseptic assurance programs and microbiological quality systems, and act as the main quality partner for microbiological and aseptic manufacturing.

Key responsibilities

• Serve as the site SME for microbiology, contamination control, aseptic processing, environmental monitoring, cleanroom qualification and operator qualification programs.
• Define and continuously improve contamination control strategies in line with EU GMP Annex 1, FDA requirements, global regulations and internal quality standards.
• Lead the design, implementation and lifecycle management of environmental monitoring, cleaning, disinfection and microbial control programs.
• Provide risk-based scientific leadership on microbiological and aseptic process challenges.
• Review and approve investigations, root cause analyses, risk assessments, deviations, CAPAs, change controls and validations.
• Oversee facility design, commissioning, qualification, process validation, media fills, smoke studies and technology transfers.
• Monitor microbiological trends and contamination events, lead regulatory inspections, audits and escalations, and drive CAPAs.
• Collaborate with Manufacturing, MS&T, Validation, Engineering, Laboratory Operations and Global Quality, and mentor colleagues.

Required profile

• University degree in Microbiology, Biology, Biotechnology, Pharmacy, Chemistry, Chemical Engineering or another relevant life science.
• At least 4 years of experience in aseptic pharmaceutical manufacturing, microbiology, contamination control, quality assurance or aseptic operations.
• Demonstrated expertise in EU GMP Annex 1 and contamination control strategies for sterile manufacturing.
• Experience leading complex investigations, risk assessments, validations and quality improvement initiatives.
• Fluent English and Slovenian.

Preferred requirements

• Experience supporting regulatory inspections and customer audits.
• Experience in biologics, biotechnology or injectable manufacturing.
• Knowledge of advanced contamination control concepts, rapid microbiological methods and data-driven quality systems.
• Previous involvement in facility start-up, commissioning, qualification or technology transfer projects.

What we offer

• Permanent contract with a 6-month probation period, 40 hours per week, in Ljubljana and Brnik.
• Annual gross salary of EUR 45,120 - 67,680 depending on experience and skills.
• Annual bonus (STI), vacation allowance, Christmas bonus, OurShare and a voluntary additional pension scheme covered by the employer.
• Collective life and accident insurance and a hybrid work environment.