QA Equipment Validation Specialistfor the site Borgo San Michele LT, Italy

QA Equipment Validation Specialist – Borgo San Michele, Italy

Would you like to make a valuable contribution to patient health and take on a meaningful responsibility? Join Aenova, a leading contract manufacturer in the pharmaceutical industry, at our Sterile Liquid Production site in Latina, Italy.

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.

Apply Now

If you have any questions, contact Lukas Rödder, Human Resources, at +49 151 16260074.

Job Details

• Seniority level: Mid‑Seniorn
• Employment type: Full‑time
• Job function: Quality Assurance
• Industry: Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Aenova Group by 2x.

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