Validation Lead on the BIO Lendava Project

On behalf of our client Sandoz, a global leader in generics and biosimilars, we are seeking an experienced Validation Lead to join their team in Lendava, Slovenia.

Sandoz is making history with one of the largest biosimilar investments in Europe, and this is your opportunity to be at the forefront of ensuring quality excellence in a state-of-the-art Biosimilars DS Manufacturing Site.

In this key leadership role, you will be responsible for developing, implementing, and managing the site process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet cGMP and quality requirements on time and within budget, ensuring compliance with regulatory authorities' expectations.

If you are an experienced validation professional with strong leadership skills and a passion for biopharmaceutical excellence, this is your chance to make a lasting impact.

👉 Apply now and help shape the future of biosimilars with Sandoz!

🔹 Please note: This is an on-site position based in Lendava, Slovenia. Relocation or commuting is required.

Your Key Responsibilities:

• Define and implement the validation strategy (process, cleaning, media status times, SIPs, product transport, periodic checks) and advocate to relevant authorities.

• Establish, prioritize, and track the validation master plan for process, cleaning, packaging, media residence times, chromatography media cycles, and periodic validation verification (OPV).

• Ensure all production, purification, and supporting processes are validated and maintain a validation status review on-site.

• Prepare complex validation protocols and review all validation documentation.

• Ensure compliance with Sandoz requirements, GMP guidelines, and regulatory standards, addressing deviations and overseeing validation linked to technical changes.

• Lead the validation team.

• Collaborate with Engineering, IT, QC, AS&T to identify contacts for equipment, systems, media, and analytical methods validation.

• Contribute to providing process data from validation for registration dossier preparation.

• Represent the site in global validation teams.

Minimum Requirements:

• Bachelor's degree in chemistry, pharmacy, chemical engineering, pharmaceutical technology, or a related field. A PhD in the above or other relevant fields is desirable.

• Minimum 5 years of experience in manufacturing/production science and technology, technical development, or quality roles.

• Proven experience leading validation projects and teams.

• Ability to work effectively in a cross-functional environment.

• Strong problem-solving and analytical skills.

• Proficiency in English; knowledge of Slovenian is a plus.

You’ll Receive:

• Employment at the most reputable employer in Slovenia

• Permanent contract with a 6-month probation period

• Competitive salary

• Annual bonus

• Flexible working schedule, tailored to your needs

• Home office options

• Pension scheme

• Employee Recognition Scheme

• Expanded program for promoting health in the areas of physical, mental, and social well-being (Energized for Life)

• Unlimited learning and development opportunities