Validation & Qualification Manager
- Noventa Padovana, Padova
- Tempo indeterminato
- Full time
- Develop, maintain, and execute the Validation Master Plan and Cleaning Validation Master Plan in alignment with regulatory expectations for veterinary biologicals.
- Lead validation efforts across bioprocessing operations including upstream (e.g., fermentation, cell culture) and downstream (e.g., aseptic filling), as well as cleaning validation in multi-product facilities.
- Support quality control for analytical method validation for critical quality attributes and ensured compliance in cold chain and temperature-controlled storage systems.
- Act as Local Management System Owner (LMSO) for Cleaning Validation, Process Validation, Environmental Monitoring, and Leva implementation for Equipment.
- Support regulatory inspections (e.g., Ministry of Healthy,) and internal audits by providing documentation and subject matter expertise.
- Manage and mentor a team of validation professionals and coordinate cross-functional contributors.
- Ensure timely closure of CAPAs, change controls, and deviation investigations related to validation.
- Collaborate with Tech Transfer teams during the scale-up and industrialization of new veterinary vaccines.
- Education: Degree in Pharmacy, Biotechnology, Veterinary Medicine, Chemical Engineering, or related scientific discipline.
- Experience: Minimum 5 years in validation within a biopharmaceutical or veterinary vaccine manufacturing environment.
- Technical Knowledge: Comprehensive expertise in biological process validation, aseptic processing, biosafety containment, and cleaning strategies for multi-product facilities, with strong familiarity with Eudralex (Annexes 1, 5, 11, 15) and VICH GLs.
- Experience in project management and cross-functional coordination
- Excellent communication and leadership skills
- Fluent in English (spoken and written); knowledge of Italian is a plus
- Strong problem-solving and risk-based thinking approach
- For this position we offer a permanent contract.
- Free access to the company canteen.
- A range of benefits for your physical, financial, social and mental wellbeing (access to gyms, pilates and yoga sessions, physiotherapist, psychologist, volunteering, parental support, company welfare and more).
- A support to develop your own professional and personal path that will guide you through our full range of development programs including platforms to learn foreign languages and attend professional courses.