GMP Validation Engineer – Pharmaceutical Equipment

Aenova Group; Latina; Hybrid; EUR 42,000 - 64,000; Full time

Job summary

Aenova Group, at the Borgo San Michele LT site in Italy, is looking for an Engineering Validation Specialist to contribute to qualification activities for manufacturing equipment, process systems, utilities and laboratory instruments. You will prepare GMP documentation (URS, DQ, IQ, OQ, PQ) and support FAT/SAT, collaborating with Engineering, Production, Quality Assurance, Validation, Maintenance, and suppliers.

A degree in science/engineering and 2–3 years of experience are required.

Qualifications

• Excellent communication skills and ability to work effectively in cross-functional and client-facing environments.
• Strong attention to detail and accuracy in GMP documentation and qualification activities.
• Ability to manage qualification activities independently and to coordinate with multiple stakeholders.

Responsibilities

• Prepare, review, and maintain GMP documentation including URS, DQ, IQ, OQ, PQ, qualification protocols and final reports.
• Coordinate qualification activities for manufacturing equipment, process systems, utilities and laboratory instruments.
• Support FAT and SAT activities and assess qualification impact of deviations, change controls and CAPAs.
• Ensure qualification documentation is generated, reviewed and archived per GMP and data integrity principles.
• Collaborate across Engineering, Production, Quality Assurance, Validation, Maintenance and external suppliers.
• Participate in regulatory inspections and customer audits as required.

Skills

Attention to detail

Communication skills

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in a scientific or engineering discipline

Tools

MS Office

Document management systems

Job description

Aenova Group, at the Borgo San Michele LT site in Italy, is looking for an Engineering Validation Specialist to contribute to qualification activities for manufacturing equipment, process systems, utilities and laboratory instruments. You will prepare GMP documentation (URS, DQ, IQ, OQ, PQ) and support FAT/SAT, collaborating with Engineering, Production, Quality Assurance, Validation, Maintenance, and suppliers.

A degree in science/engineering and 2–3 years of experience are required.