Position Description:
The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. 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.

REQUIREMENTS INCLUDE:

Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
5+ years experience with Computer systems validation
Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is preferred
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, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future

BENEFITS

Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.

LI-MV1

Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO)

Please refer the Job description for details