Validation Lead (m/f/d)

About the role

Novartis is looking for a Validation Lead for its Ljubljana Aseptic Manufacturing site, which is being built as a global centre of excellence for aseptic medicines. The role leads process, cleaning, packaging and revalidation strategies and ensures validation compliance with GMP, internal rules, legislation and quality standards. It is a hybrid position in Ljubljana, Slovenia, with no relocation support offered.

Key responsibilities

• Develop and execute validation strategies for processes, cleaning, packaging and ongoing process verification
• Ensure validation compliance with GMP, internal policies, legislation and quality standards
• Maintain the site validation master plan and monitor validation status
• Prepare validation protocols and documentation and lead validation activities
• Advise on risk assessments and validation strategies for new products
• Take part in product transfers and launches and support registration documentation
• Coordinate with Engineering, IT, QC and AS&T on qualifications and validations
• Host validation board meetings and represent the site in the validation network
• Support training of colleagues and manage training curricula

Required profile

• University degree in natural sciences, pharmacy or a technical field
• Experience in process, cleaning and packaging validation in a regulated environment (at least 5 years preferred)
• Strong knowledge of GMP and pharmaceutical legislation
• Fluent English, written and spoken; Slovenian is an advantage

Required skills

• Ability to prepare validation documentation and lead validation activities
• Risk assessment and use of risk management tools
• Experience collaborating with IT, QC and engineering teams

What we offer

• Permanent employment with a 6-month probation period
• Competitive salary, annual bonus and flexible working, including the option to work from home
• Pension scheme and employee recognition scheme
• Expanded health and well-being programme and learning and development opportunities