Remote

CSV Engineer

Solothurn
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Beschreibung

CSV Engineer

Experis IT Switzerland is in a search of a CSV Engineer to join one of their clients, a well renowned pharmaceutical company. Due to business expansion, they are seeking a talented professional to join their existing team.

Start Date: ASAP
Duration: 12 months (with hight chances for an extension)
Location: Solothurn (4 days remote work/1 day on site)

MAIN RESPONSIBILIES:

. Creation of test plans in Kneat (validation software), for testing the computer systems in Biopharma installation.
. Validation of software and test scripts as well as Excel workbooks according to CSV Computerized System Validation), which ensure test processes/results from the production environment and link them to databases
. Qualification of equipment, such as standard equipment, measuring equipment or test/inspection systems (custom built, consisting of various subsystems including software components)
. Validation of test software for the DCS used for process control System and MES system according to CSV (Computerized System Validation plan)
. Execution of software tests, including the creation of test reports and creation of risk analyzes for equipment/software/systems
. QMS activities, change control and deviations review and approval

REQUIREMENTS:

. University or technical college degree or equivalent training in one of the subjects: medical technology, computer science, engineering or physics.
. Several years of experience in validation, qualification and CSV (Computer System Validation) and software development.
. Very good experience in writing test plans for software and in the regulated GxP environment, ideally in Biotech using: ISO 13458,. cGMP,. GAMP 5. FDA 21 CFR part 820.70. FDA 21 CFR part 11.10. FDA 21 CFR part 11. EUROPEAN COMMISSION, HEALTH AND CONSUMERS DIRECTORATE-GENERAL Annex 11: Computerised Systems
. High technical understanding of test/process sequences and good knowledge of mathematics in formula calculations for independent verification
. You communicate efficiently and successfully in a complex environment with many interfaces and you are a team-oriented, flexible and resilient personality with very good networked thinking
. Independent and precise work, characterized by a high degree of responsibility and service orientation
. Very good knowledge of English

If you are interested, please send us your CV.


Start
ab sofort
Dauer
12
Von
Experis AG
Eingestellt
04.08.2022
Projekt-ID:
2438888
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