Engineering Validation Specialist

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

for the site Borgo San Michele LT, Italy

Your key responsibilities

The Engineering Validation Specialist is responsible for planning, executing, documenting, and maintaining qualification activities for GMP equipment and utilities used in pharmaceutical manufacturing environments in compliance with applicable regulations (laws, GMP, FDA, etc.), the guidelines contained in the dossier, and company quality standards.

• 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!

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