Validation Expert I (d/f/m)

SummaryThe future is ours to shape.

Job Description

Join us as a Validation Expert and be the key to ensuring our pharmaceutical products meet the highest quality standards. You'll lead crucial validation projects for processes, packaging, and cleaning, keeping us compliant with global regulations and driving continuous improvement. If you're passionate about precision and quality, and want to make a real impact, we want you on our team.

Join us as a Founder of our ‘new’ Sandoz and Lek!

Your key responsibilities:

Your responsibilities include, but not limited to:

Support Product Steward in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.

Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).

Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring.

Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.

Support validation lead for KPI reporting.

Ensure that all Site validation activities are performed and are in line with requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.

Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.

Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation and support the execution of validation activities on the shop floor.

What you will bring to the role:

BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical

Technology.

Minimum 2-3 years experience in manufacturing/ manufacturing science and

technology/technical development/quality.

Functional knowledge of English.

Strong analytical and problem-solving abilities.

Excellent communication and teamwork skills.

Meticulous attention to detail and organizational skills.

Ability to work independently and manage time effectively.

Proactive and adaptable mindset.

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.

Possible job locations: Slovenia (Lendava)

We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in English, including your CV, by May 4th, 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.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:

#BIORampUp #Sandoz

Skills Desired

REQ-10036729