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 - 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.

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.

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).

Note

Please note: Applications must be submitted in English . Applications in Italian or any other language will not be considered .

Haupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT, Italy

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📌 QA Equipment Validation Specialist (Latina)
🏢 SwissCo Services AG / Aenova Group
📍 Latina