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Senior Engineer CSV (m/w/d)
Exyte GmbH
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted yesterday
About this role
Discover your exciting role Join us in delivering innovative projects for the pharmaceutical and biotechnology industries. In this role, you will ensure the compliance and validation of computerized systems while contributing to high-quality solutions in GMP-regulated environments. Explore your tasks and responsibilities Independently plan and execute Computerized System Validation (CSV) projects within GMP-regulated environments. Prepare and execute risk-based validation documentation and validation activities. Perform GMP gap analyses and risk assessments for computerized systems. Advise clients on IT quality management and compliance-related topics. Develop and improve CSV-related quality processes, policies, and SOPs. Conduct trainings, workshops, and IT compliance audits. Support CAPA implementation and follow-up activities. Show your expertise Degree in Computer Science, Automation Engineering, Engineering, Pharmaceutical Technology, Life Sciences, or a related discipline. Minimum 5 years of professional experience in computer system validation and/or IT infrastructure qualification within the life sciences industry. Strong knowledge of relevant regulations and standards, including EU GMP, 21 CFR Part 11, ISO 13485, and MDR. Experience with risk-based validation methodologies and GMP compliance requirements. Strong analytical and problem-solving skills. Fluent in both German and English. Willingness to travel combined with a strong customer and service-oriented mindset. What we offer • International Project Environment: Work in an international environment on complex large-scale projects for the pharmaceutical, semiconductor, and data center industries, helping to shape the technologies of tomorrow. • Structured Onboarding: Kick-start your career with a two-day onboarding event. Afterwards, our Buddy Program provides you with several weeks of dedicated support and hands-on training from experienced team members, ensuring a smooth professional and personal integration into your new role. • Health & Fitness: Stay active! Exyte subsidizes your EGYM Wellpass membership, giving you access to more than 5,000 fitness and wellness facilities across Germany. • Sustainable Mobility: Benefit from attractive mobility programs, including a subsidized Germany Ticket (Deutschlandticket) or the option to lease a bicycle through our JobBike/JobRad program, supporting a sustainable and flexible commute. • Employee Benefits: Enjoy exclusive discounts and special offers through our Corporate Benefits platform, with savings on shopping, travel, leisure, technology, and much more. • Company Pension Scheme: Plan for your future with confidence. We support your long-term financial security by contributing to your company pension plan. Contact: You want to be part of the Exyte team? We look forward to receiving your application! For further questions and information, please do not hesitate to contact Ugur Guezel via E-Mail at ugur.guezel@exyte.net. Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.