Engineering Equipment & CSV Manager
Engineering Equipment & CSV Manager
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Job Description
Engineering Equipment & CSV Manager
for the site Borgo San Michele LT Italy
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 - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production with a strategic investment plan to become one of Europes foremost hubs.
Your key responsibilities
- Oversee the qualification activities of plants equipment classified environments and critical systems according to GMP regulations.
- Oversee the coordination of qualification activities with the departments involved: Engineering Production Quality Maintenance and HSE.
- Quantify the budget.
- Provide the necessary support during internal and external audits regulatory inspections and periodic review activities of qualified systems.
- Ensure the traceability compliance and integrity of data generated during qualification activities.
- Monitor the qualification status of corporate assets and manage the life cycle of systems according to corporate policies.
Your profile
- Degree in scientific or engineering disciplines (e.g. Chemistry Biotechnology Engineering Pharmaceutical Chemistry and Technology).
- Minimum 5 years experience in the field of qualification/validation in pharmaceutical companies.
- In-depth knowledge of GMP GAMP and major international standards (e.g. FDA EMA).
- Precision attention to detail and ability to manage activities independently.
- Good interpersonal skills and ability to work in cross-functional teams.
- Knowledge of English (B2).
- Proficiency with the main IT tools (MS Office document management systems ERP).
Your motivation
Are you looking for new challenges in a highly competitive environment And you want to tackle them creatively and on your own responsibility Do you prefer a get-it-done culture and think in terms of solutions rather than problems What are you waiting for We would be happy to explain our corporate benefits in a personal conversation!If you have any questions I - Chiara Fanasca / Human Resources - will be happy to help you:
Haupt Pharma Latina S.r.l. Member of the Aenova Group Strada Statale 156 dei Monti Lepini 04100 Borgo San Michele LT ItalyRequired Experience:
Manager
Employment Type
Full-Time
