About CAICAI 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 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.As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrityWe serve each otherWe serve societyWe work for our futureWith 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. BenefitsOur 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.Requirements include: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. 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. Position Requirements: BS in a Computer Science or Engineering field or equivalent experience2-15 years’ experience with Computer systems validationExperience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is preferredExperience in biotech and pharma is preferred over medical deviceExcellent 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 Other Requirements:Excellent oral and written English is requiredAble 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 futureMust have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment#LI-JN1We 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).