We are hiring a Computer System Validation Engineer for a leading Pharmaceutical company in Switzerland.
The essential responsibilities required are:
- 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, 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 · Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups · Coordination and oversight of external subcontractors / software suppliers · 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.
German language is a must.
If this is something of interest, click Apply Now below and we will set up a call to discuss.
Looking forward to hearing from you soon.