Process Expert I

Job Description
Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz and Lek

Process Expert I
will provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...). Support smooth operation of production, with the aim of improving quality and compliance. Responsibility for upgrading and transfer of expertise, assessment and implementation of new technologies, and contribution to the development process optimization.

Your Key Responsibilities

• Provide front line expert support for complex issues and challenges, related to processes and production.
• Act as Subject Matter Expert (SME) for specific techniques, products or technical processes.
• Ensure on time shop floor support as an expert on technical problems and ensure that appropriate immediate corrective actions are implemented.
• Ensure that all complex production documents, project timelines and/or validations are systematically and timely up to date for the need of regular production, in compliance with GMP.
• Lead thorough Root Cause Investigation process using investigation tools and methodology (e.g. Fishbone, rapid RCI, 5why etc.).
• Lead complex investigations of deviations and cooperate with experts from other relevant units if applicable.
• Lead and monitor the process of managing complex changes using appropriate change management procedures and tools (e.g. FMEA analysis etc.).
• Prepare and actively participate in all inspections and prepare and implement measures, based on audits' observations.
• Manage validations, revalidations / qualifications and annual reviews, in accordance with deadlines and current regulations.
• Ensure that all process changes in assigned products are managed through appropriate change control procedure.

What You Will Bring To The Role

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
• Fluency in English and proficiency in Slovene language
• Minimum 3 year experience in process support role on the shop floor of GMP manufacturing and/or QA/QC

You'll Receive
Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.

Job location:
Mengeš
, Slovenia

We offer
a permanent contract with 6-month of probation period
. You are kindly invited to submit your application in English or Slovene language, including CV, by the
2nd
of December 2025.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is ours to shape

Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.