Csv Expert

**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.

To strengthen our team in **Switzerland**, we are looking for a **CSV Expert (M/F/x).**

**ABOUT THE JOB**:
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:

- Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- 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 5 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 French
- Experience on validating complex computerized analytical equipment (QC Laboratory equipment)
- Basic know-how of Validation requirements according to cGMP regulations

**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"

**Job Types**: 100%, Permanent

Schedule:

- Monday to Friday

Work Location: In person