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

Aenova Group; Latina; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading contract manufacturer in the pharmaceutical industry is seeking a QA Equipment Validation Specialist at their Sterile Liquid Production site in Latina, Italy. The role requires expertise in validation, strong documentation skills, and the ability to work in compliance with industry standards. Candidates should have a degree in a scientific or engineering discipline and relevant experience in pharmaceutical validation. This is a full-time position offering a meaningful opportunity to contribute to patient health.

Competenze

• Previous experience in the pharmaceutical industry is essential.
• 2-3 years of experience in qualification/validation within pharmaceutical companies.
• In-depth knowledge of GMP, GAMP, and major international standards (FDA, EMA).

Mansioni

• Provide expertise in validation ensuring compliance with industry regulations.
• Review and approve qualification and validation protocols and reports.
• Prepare and maintain validation-related SOPs and policies.

Conoscenze

Validation expertise

Technical documentation skills

Excellent interpersonal and communication skills

Team-oriented mindset

Strong IT skills (MS Office)

Formazione

Degree in a scientific or engineering discipline

Strumenti

MS Office

ERP systems

Document management systems

Descrizione del lavoro

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 [phone].

Job Details

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

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