Vodja validacij (m/ž/d) / Validation Lead (m/f/d)
Core
Lead the development and execution of validation strategies for manufacturing processes, cleaning, and packaging to ensure safe, effective, and compliant operations in a regulated pharmaceutical environment.
Role type
Senior IC Validation Lead (Manufacturing)
Builds
Validated manufacturing processes, cleaning and packaging protocols, and regulatory documentation for new product introductions.
Domain
Pharmaceutical manufacturing / Process Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Cleaning validation, Packaging validation, GMP compliance, Risk assessment, Validation documentation, Cross-functional coordination, Training management
Preferred skills
Statistical analysis, Change control, Data analytics, Technology transfer, Operational excellence
Technologies
None explicitly stated
Responsibilities
Develop and execute validation strategies for processes, cleaning, and packaging; Establish and maintain the site validation master plan; Prepare validation protocols and documentation; Advise on risk assessments for new product introductions; Coordinate with Engineering, IT, QC, and AS&T; Host validation board meetings; Support training and development of team members.
Seniority
Senior, hands-on IC
