CAI

Computer System Validation Engineer

Viewed 1 time

Job Description

The Computer System 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

  • BS in a STEM field or equivalent years of experience
  • 2-8 years’ experience with Computer systems validation in the USA
  • 2 years’ experience working in a GMP environment
  • Experience with GAMP 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, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc.
  • 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. We do not sponsor OPT, H-1B, L-1 or corp to corp
  • 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 FCO. CAI is proud to be an Equal Opportunity Employer.

Bonus Points

  • 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.

Job Summary

wave-1-bottom
RALEIGH, NORTH CAROLINA /REGIONAL OPERATIONS – SOUTH ATLANTIC Location
Full Time Job Type
CAI

About

CAI is a 100% employee-owned company established in 1996 that has grown to more than 600 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. Please check CAI out on Glassdoor to get a better perspective on our culture. We are extremely proud that so many of our employee owners have given us so many 5-star ratings. Meeting a Higher Standard Our 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. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: We act with integrity We serve each other We serve society We work for our future With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.

Similar Jobs

The largest community on the web to find and list jobs that aren't restricted by commutes or a specific location.

  • Wood Applied Intelligence

    Wood is currently recruiting for an Automation Sector Leader – Life Sciences to lead and grow our capabilities in the Pharmaceutical and Biotech market. This is a highly visible role, and the opportunity to build on Wood’s global experience to develop a new part of the business. The ideal candidate will have experience in all phases of Automation projects combined with a strong interest in developing new business. For the right candidate, this position can be seated out of any city in the US where Wood has a local office, but will report to the team based in Greenville, SC

  • Rymedi

    We are seeking a highly motivated and detail-oriented Software Engineer experienced in developing web applications. You will work with many AWS offerings and open-source tools, helping define Rymedi’s next-generation software.