CSV Engineer – Life Sciences (DE)
- 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!