For the site Borgo San Michele LT, Italy
Engineering Equipment & CSV Manager
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.
Your key responsibilities
* Oversee the qualification activities of plants, equipment, classified environments, and critical systems according to GMP regulations.
* Coordinate qualification activities with involved departments: Engineering, Production, Quality, Maintenance, and HSE.
* Quantify the budget for qualification activities.
* Support internal and external audits, regulatory inspections, and periodic reviews of qualified systems.
* Ensure traceability, compliance, and data integrity during qualification activities.
* Monitor qualification status of corporate assets and manage system lifecycle according to policies.
Your profile
* Degree in scientific or engineering disciplines (e.g., Chemistry, Biotechnology, Engineering, Pharmaceutical Chemistry and Technology).
* Minimum 5 years’ experience in qualification/validation in pharmaceutical companies.
* Deep knowledge of GMP, GAMP, and international standards (e.g., FDA, EMA).
* Attention to detail and ability to manage activities independently.
* Good interpersonal skills and team collaboration abilities.
* English proficiency (B2 level).
* Proficiency with IT tools (MS Office, document management systems, ERP).
Your motivation
Are you seeking new challenges in a competitive environment? Do you want to approach them creatively and responsibly? If you prefer a 'get-it-done' culture and solution-oriented thinking, what are you waiting for? We look forward to discussing our corporate benefits with you in a personal conversation!
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