CAI is a 100% employee-owned company established in 1996 that has grown to over 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.
CAI CSV Engineers will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to patients. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our employees benefit from our role as the leading commissioning / qualification firm in the world.
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. Work may be performed remotely (especially document generation), but some on-site presence at the client site should be expected. 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.
BS in a Computer Science or Engineering field or equivalent experience
2-15 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
Excellent technical problem-solving and basic troubleshooting skills.
High attention to detail.
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
Ability to work independently, while supporting other team members.
Proficiency in Microsoft Word and Excel
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment