THE POSITION
The Validation & Qualification Manager is responsible for leading all validation and qualification activities at a veterinary vaccine manufacturing site, ensuring compliance with GMP standards specific to biological and immunological veterinary products (e.g. Annex 1, Annex 5, Annex 11, Annex 15, ecc). The role ensures that all systems, processes, and equipment used in the production of sterile veterinary vaccines are validated and maintained in a state of control, contributing to global validation strategy and continuous improvement initiatives.
Responsibilities
- 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.
Requirements
- 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
What we offer
- 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.
In Boehringer Ingelheim we are committed to guarantee equal opportunities; we believe in respect, trust and empathy, in a work environment without discrimination. We are powered by our people as we know that our differences are our strengths. We value everyone and we aim that each of us feels included, important and at ease.
This job requisition is addressed also for candidates with disabilities and belonging to protect categories following articles 1 and 18, Law 68/99.