CSV Engineer – Life Sciences (DE)

ALTEN Group

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 57,000 engineers, carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defence & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

ALTEN Switzerland

Since 2005, with 450 current employees, ALTEN Switzerland is a reference partner in providing Engineering services to 100 world leading companies. ALTEN Switzerland’s activities cover all the main strategical areas of the Swiss market in Life Sciences, Engineering & IT Services.

• Assess and lead specific assigned CSV package(s)
• Hands on: Plan, coordinate and execute all phases for computer system validation of production and/or QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
• Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
• Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
• Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
• Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV Support Technical Services department KPI.
• Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures
• Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.

• Bachelor / Master degree in Life Sciences, biotechnology, chemistry or related filed
• Significant experience in computerized system validation (CSV) in a GMP environment
• Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
• Strong analytical thinking and problem-solving ability
• Excellent communication and teamwork skills
• Fluent in English and/or German
• Multiple options for locations: Bern, Zurich, Basel, Schaffhausen

What we offer you

At Alten, we offer you the security of a permanent contract while also giving you the liberty to work with multiple prestigious clients. With the luxury of having a wide range of offices around the world, we are in a unique position to provide you with the freedom to experience national and international business opportunities. Thus, we function in a highly innovative market, always being up to date with the latest technologies and making you a pioneer in your field. Therefore, we offer our employees sought-after trainings and workshops ranging from hard to soft skills and providing you with certificates that will further increase your qualifications, enabling you to participate in ground-breaking projects.

Apply now and be a part of our amazing journey. We believe in growing together!