CSV junior Engineer

Milano  /  South Europe  /  Full Time

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



(Varies by Country, Below is a General Overview)

  • Comprehensive Health Insurance coverage aligned with local region regulations
  • Paid Time Off
  • ESOP/401K – 15% Company Contribution (US Only)
  • 15% Company Pension Contribution (Europe and APAC Regions)
  • Company Paid Life Assurance
  • Company Paid Income Protection/Long-Term Disability
  • Career/Professional Development Opportunities
  • Additional benefits/leave entitlements based on local regional requirements.
  • Other Benefits Depending on Country