pfor the site Borgo San Michele LT, Italy /p h3Your key responsibilities /h3 pThe 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. /p ul liPrepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations. /li liEnsure 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 /li liCoordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments. /li liSupport Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). /li liAssess qualification impact of deviations, change controls, CAPAs, and maintenance activities. /li liEnsure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles. /li liCollaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion /li liParticipate in regulatory inspections and customer audits, providing technical support and qualification documentation as required. /li liContribute to the development and continuous improvement of qualification procedures, templates, and validation strategies. /li liIn 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. /li /ul h3Your profile /h3 ul liBachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry, Biotechnology, Engineering, Pharmacy). /li liMinimum 2-3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations. /li liSolid knowledge of GMP and relevant international regulatory standards (EMA, FDA). /li liProven experience in the preparation and management of GMP documentation in regulated environments. /li liHands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill Finish operations for biologics preferred. /li liKnowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP). /li liStrong attention to detail, accuracy, and ability to manage qualification activities independently. /li liExcellent communication skills and ability to work effectively in cross-functional and client-facing environments. /li liGood command of the English language (minimum B2 level). /li liProficiency in standard IT tools, including MS Office, document management systems. /li /ul h3Your motivation /h3 pAre 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! /p pHaupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT, Italy /p #J-18808-Ljbffr

📌 Engineering Validation Specialist (Latina)
🏢 SwissCo Services AG / Aenova Group
📍 Latina