QA Equipment Validation Specialist

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

• 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.
• 23 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