Engineering Validation Specialist

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

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.

Engineering 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 - 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.

Your key responsibilities

• Prepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations.
• Ensure the analysis and evaluation of raw technical data and documentation related to equipment and instruments subject to qualification, in order to acquire the information necessary for defining procedures/protocols
• Coordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments.
• Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
• Assess qualification impact of deviations, change controls, CAPAs, and maintenance activities.
• Ensure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles.
• Collaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion
• Participate in regulatory inspections and customer audits, providing technical support and qualification documentation as required.
• Contribute to the development and continuous improvement of qualification procedures, templates, and validation strategies.
• In collaboration with the Purchasing Department, prepare requests for quotation to suppliers and support the Manager in preparing a technical and economic evaluation of the offers received.

Your profile

• Bachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry, Biotechnology, Engineering, Pharmacy).
• Minimum 2–3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations.
• Solid knowledge of GMP and relevant international regulatory standards (EMA, FDA).
• Proven experience in the preparation and management of GMP documentation in regulated environments.
• Hands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill & Finish operations for biologics preferred.
• Knowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP).
• Strong attention to detail, accuracy, and ability to manage qualification activities independently.
• Excellent communication skills and ability to work effectively in cross-functional and client-facing environments.
• Good command of the English language (minimum B2 level).
• Proficiency in standard IT tools, including MS Office, document management systems.

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation!