Pharma Equipment Validation Engineer - GMP Expert

SwissCo Services AG / Aenova Group; Latina; On-site; EUR 45,000 - 65,000; Full time

Job summary

Haupt Pharma Latina S.r.l., a member of the Aenova Group, is seeking an Engineering Validation Specialist for its site Borgo San Michele LT, Italy. You will plan, execute, and maintain GMP qualification activities for equipment and utilities used in pharmaceutical manufacturing.

Ideal candidates have 2–3 years in qualification/validation in pharma or biotech, with hands-on isolator experience, and strong GMP knowledge. Excellent cross-functional collaboration and English (B2) are required.

Qualifications

• Solid knowledge of GMP and relevant international regulatory standards (EMA, FDA).
• Experience in preparation and management of GMP documentation in regulated environments.
• Hands-on experience with isolator technology, especially aseptic/sterile Fill & Finish for biologics.
• Knowledge of Equipment and Utilities validation regulations, incl. sterile departments (isolator, autoclave, tunnel, VHP).
• Strong attention to detail and ability to manage qualification activities independently.
• Excellent communication skills and ability to work cross-functionally with clients.

Responsibilities

• Prepare, review, and maintain GMP documentation (URS, DQ, IQ, OQ, PQ, protocols, reports).
• Analyze raw technical data to define procedures and protocols.
• Coordinate qualification activities for equipment, process systems, utilities, and lab instruments.
• Support FAT and SAT activities.
• Assess qualification impact of deviations, change controls, CAPAs, and maintenance.
• Ensure qualification docs are generated, reviewed, and archived per GMP and data integrity standards.
• Collaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and suppliers for timely project completion.
• Participate in regulatory inspections and customer audits, providing technical qualification docs as needed.
• Contribute to development and improvement of qualification procedures and validation strategies.
• Assist Purchasing in preparing RFQs and evaluating technical/economic offers.

Skills

GMP knowledge

Documentation management

Cross-functional collaboration

Communication

English (B2)

MS Office

Education

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

Tools

MS Office

Document management systems

Job description

Haupt Pharma Latina S.r.l., a member of the Aenova Group, is seeking an Engineering Validation Specialist for its site Borgo San Michele LT, Italy. You will plan, execute, and maintain GMP qualification activities for equipment and utilities used in pharmaceutical manufacturing.

Ideal candidates have 2–3 years in qualification/validation in pharma or biotech, with hands-on isolator experience, and strong GMP knowledge. Excellent cross-functional collaboration and English (B2) are required.