Junior Computer System Validation Engineer Based In Bologna Italia - BOLOGNA, Italia - Cagents

Descrizione

Junior Computer System Validation Engineer Based in Bologna Italia Bologna / South Europe /

Full Time 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 experience1-3 years' experience with Computer systems validation1 years' experience working in a GMP environmentExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is a plusExperience in biotech and pharma is preferred over medical deviceExperience 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(Varies by Country, Below is a General Overview)100% Employee Owned24 Days PTO/5 Sick days per year + Additional Holidays depending on CountryMedical / Dental / Vision (In accordance with each countries' applicable regulations)Professional Development (Approximately $5,000 paid career-related, continuing education)ESOP/401k – 15% Company ContributionCompany Paid Long-Term DisabilityCompany Paid Life InsuranceCompany Paid Parental Leave (In accordance with each countries' applicable regulations)#J-18808-Ljbffr