CSV Engineer

Overview  CAI is a professional services company established in 1996 that serves Life Sciences and Mission Critical industries with optimized operational readiness and performance. This description reflects a Computer Systems Validation (CSV) Engineer role focused on GxP validation in regulated environments.

Key Responsibilities   The 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
2-7 Years’ Experience With Computer Systems Validation
2 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21

CFR Part 11 experience is highly desired
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, Factory Talk, Pharma Suite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able To Travel Domestically And Internationally As Required
La selezione rispetta il principio delle pari opportunità (l. 903/77)
Seniority level   Not Applicable

Employment type

Full-time
Job function   Engineering and Information Technology
Pharmaceutical Manufacturing

Location:

Metropolitan City of Bologna, Emilia-Romagna, Italy

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