Location: Borgo San Michele LT, Italy
QA Equipment Validation Specialist
Would you like to make a valuable contribution to the health of patients and do something really meaningful on your own responsibility? 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
* Provide expertise in validation, ensuring compliance with industry regulations, guidelines, and trends.
* Review and approve qualification and validation protocols, reports, and related documentation, including premises, equipment, and utilities.
* Prepare and maintain validation-related SOPs and policies; assess change controls for validation impact.
* Troubleshoot validation deviations, participate in revalidation programs, and support cross-functional projects as QA validation representative.
* Maintain organization and archival of all validation and qualification documentation.
* Act as point of contact for customers during audits, inspections, and validation-related discussions, ensuring professional and solution‑oriented communication.
Your profile
* Degree in a scientific or engineering discipline (e.g., Chemistry, Biotechnology, Engineering, Pharmaceutical Chemistry).
* Previous experience in the pharmaceutical industry is highly valued and essential for this role.
* 2–3 years of experience in qualification/validation within pharmaceutical companies.
Experience in sterile manufacturing (Fill & Finish) is a strong advantage.
* In‑depth knowledge of GMP, GAMP, and major international standards (FDA, EMA).
Strong technical documentation skills, attention to detail, and ability to work independently.
* Excellent interpersonal and communication skills, with confidence in direct customer interactions.
Team‑oriented mindset and strong IT skills (MS Office, ERP, document management systems).
Please note: Applications must be submitted in English. Applications in Italian or any other language will not be considered.
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 – Lukas Rödder / Human Resources – will be happy to help you: +49 151 16260074
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