Csv Engineer
3 settimane fa
We are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.About CAICAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide.
We provide commissioning, qualification, validation, start-up, project management, and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.Meeting a Higher StandardOur approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.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 experience2-7 years' experience with Computer systems validation2 years' experience working in a GMP environmentExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desiredExperience 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 EnglishAble to travel domestically and internationally as required(Varies by Country, Below is a General Overview)Comprehensive Health Insurance coverage aligned with local region regulationsPaid Time OffESOP/401K – 15% Company Contribution (US Only)15% Company Pension Contribution (Europe and APAC Regions)Company Paid Life AssuranceCompany Paid Income Protection/Long-Term DisabilityCareer/Professional Development OpportunitiesAdditional benefits/leave entitlements based on local regional requirements.
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BOLOGNA, Italia Cai A tempo pienoBolognaEMEA Pharma – South Europe /Full Time/ HybridWe are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.About CAICAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other...
