Stiamo ricercando un Junior CSV Engineers con: 1-3 anni di esperienza e almeno un anno di esperienza nel campo delle GMP. Assunzione a tempo indeterminato; area di lavoro preferenzialmente provincia di Milano[; è richiesta disponibilità a trasferte.
Position Description:
The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
1-3 years’ experience with Computer systems validation
1 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is a plus
Experience in biotech and pharma is preferred over medical device
Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
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CAI
CAI is a 100% employee-owned company established in 1996, providing commissioning, qualification, validation, start-up, project management and consulting services to FDA regulated and other mission critical industries
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