Engineering Validation Specialist
pfor the site Borgo San Michele LT, Italy /ppWould 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. /ph3Engineering Validation Specialist /h3pfor the site Borgo San Michele LT, Italy /ppWould 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. /ph3Your key responsibilities /h3ulliPrepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations. /liliEnsure 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 /liliCoordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments. /liliSupport Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). /liliAssess qualification impact of deviations, change controls, CAPAs, and maintenance activities. /liliEnsure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles. /liliCollaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion /liliParticipate in regulatory inspections and customer audits, providing technical support and qualification documentation as required. /liliContribute to the development and continuous improvement of qualification procedures, templates, and validation strategies. /liliIn 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 /ulh3Your profile /h3ulliBachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry,
Biotechnology, Engineering, Pharmacy). /liliMinimum 2–3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations. /liliSolid knowledge of GMP and relevant international regulatory standards (EMA, FDA). /liliProven experience in the preparation and management of GMP documentation in regulated environments. /liliHands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill Finish operations for biologics preferred. /liliKnowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP). /liliStrong attention to detail, accuracy, and ability to manage qualification activities independently. /liliExcellent communication skills and ability to work effectively in cross-functional and client-facing environments. /liliGood command of the English language (minimum B2 level). /liliProficiency in standard IT tools, including MS Office, document management systems. /li /ulh3Your motivation /h3pAre 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 #J-18808-Ljbffr
in order to acquire the information necessary for defining procedures/protocols /liliCoordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments. /liliSupport Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). /liliAssess qualification impact of deviations, change controls, CAPAs, and maintenance activities. /liliEnsure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles. /liliCollaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion /liliParticipate in regulatory inspections and customer audits, providing technical support and qualification documentation as required. /liliContribute to the development and continuous improvement of qualification procedures, templates, and validation strategies. /liliIn 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 /ulh3Your profile /h3ulliBachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry,
Biotechnology, Engineering, Pharmacy). /liliMinimum 2–3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations. /liliSolid knowledge of GMP and relevant international regulatory standards (EMA, FDA). /liliProven experience in the preparation and management of GMP documentation in regulated environments. /liliHands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill Finish operations for biologics preferred. /liliKnowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP). /liliStrong attention to detail, accuracy, and ability to manage qualification activities independently. /liliExcellent communication skills and ability to work effectively in cross-functional and client-facing environments. /liliGood command of the English language (minimum B2 level). /liliProficiency in standard IT tools, including MS Office, document management systems. /li /ulh3Your motivation /h3pAre 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 #J-18808-Ljbffr