Switzerland Job Openings

ALTOGEN AG

CSV Engineer (m/f/x)

Basel

FULL TIME

September 4, 2024

ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
Learn more about us on our webpage: www.altogen.ch
To strengthen our team in Switzerland, we are looking for a CSV Engineer (m/f/x) to start asap.
ABOUT THE JOB:
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
o Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
o Validation Master plans are up to date and established for all ongoing projects

· Assess and lead the CSV package(s) on an assigned project.
Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position
Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, Validation Reports.
Perform CSV periodic review of equipment and systems.
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
Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
Coordination and oversight of external subcontractors / software suppliers when required
Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV
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 are assessed and resolved.

ABOUT YOU:

Bachelor/master’s degree in technical or natural sciences
A minimum of 4 years of working experience with CSV
Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
Ability to effectively work as part of a multidisciplinary, international team
Fluency in English and in German
Experience on validating complex computerized analytical equipment (QC Laboratory equipment)
Basic know-how of Validation requirements according to c GMP regulations

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.
WHAT WE OFFER:

A permanent contract and innovative projects
An attractive remuneration policy
Personalized management and continuous learning to develop your career
Great team spirt and an integration within the "Tribe"

If you want to join a dynamic and ambitious company? Altogen is made for you. Send us your application
Job Types: 100%, Permanent
Schedule:

Monday to Friday

Work Location: In person

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