CAI 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 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.
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.
As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.
To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.
The Validation/Computer Systems Validation Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution.
BS in a Computer Science or Engineering field or equivalent experience
5-10 years’ experience with Computer systems validation/validation in the USA
Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, 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
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment