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Csv (computer system validation) engineer - life sciences

Seregno
-
Ingegnere di validazione
Pubblicato il 12 dicembre
Descrizione

PpAre you a professional looking for a new challenge in a dynamic and fast developing business? We invite you to join our team as a CSV (Computer System Validation) Engineer - Life Sciences to be based in bSeregno, Italy /b within the bSystems and Solutions /b organization. With experience within pharmaceutical environment and automation projects related to bDistributed Control Systems (DCS) /b, Lifecycle Services, and Software Solutions you will play a key role in developing and maintaining Quality Systems for life‑science industry projects. We are looking for someone who will act as the Quality "voice," supporting both project teams and the wider department to ensure high standards and compliance are consistently achieved. This role is ideal for someone eager to grow and develop with the support of an experienced colleague, offering opportunities to learn and collaborate at a European level. /p pLet’s go! We are eager to train you and support you as you grow into a key quality champion for life‑science projects, shaping processes, ensuring compliance, and making an impact from day one. /p h3In This Role, Your Responsibilities Will Be: /h3 ul liFoster a strong quality culture within the Manufacturing Execution System and DeltaV life‑science project team, ensuring alignment to procedures and clarity on individual responsibilities. /li liProvide compliance and risk management guidance, supporting the development of strategies to mitigate project risks. /li liDevelop test strategies and test plans, train testers (including customers), support test execution, collect evidence, and prepare test reports. /li liEnsure focus on user requirements, coordinate project traceability, and review project documentation including functional specifications, configuration specifications, design specifications, and test specifications. /li liAssist in project quality reporting, track quality issues, and support solutions. /li liSupport the preparation and communication of project quality plans, lessons learned, and other quality‑relevant documentation. /li liDevelop, implement, and enforce document control, configuration management, and change management procedures on projects. /li liParticipate in project quality audits and support the Computer System Validation Lead Engineer and Quality Department in maintaining schedules and tracking outcomes. /li /ul h3Who You Are: /h3 pYou are a junior professional with hands‑on experience in life‑science projects, eager to support validation activities and ensure alignment. You actively listen, adapt your communication to meet the needs of diverse partners, and anticipate customer needs to deliver services beyond expectations. You leverage customer insights to guide improvements and new offerings, and you collaborate effectively to help others across the organization achieve shared objectives. You have a technical background and a strong focus on delivering accurate, high‑quality results in a regulated environment. /p h3For This Role, You Will Need: /h3 ul liTechnical degree or equivalent (MSc preferred, Engineering or Pharmaceutical/Biomedical background a plus). /li liUp to 2 years of experience in pharmaceutical plant environments. /li liKnowledge of computer system validation (GAMP) and all validation activities in pharma projects. /li liExperience supporting validation master plans, reviewing customer documentation, and supervising testing (FAT, SAT). /li liProficiency in English and Italian language. /li liOpen to travel to customer sites (30%). /li liDriving licence. /li /ul h3Preferred Qualifications that Set You Apart: /h3 ul liAbility to work within a complex matrix organization and collaborate across business units. /li liIn‑depth knowledge of pharma industry. /li liKnowledge of current pharmaceutical industry regulations and standards for computerized system validation is a plus. /li /ul pNo calls or agencies please. /p /p #J-18808-Ljbffr

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