Computer System Validation Engineer Staff 2

Company: CAI
Location: Minneapolis
Posted on: March 19, 2023

Job Description:

We are seeking CSV Engineers with 2-4 years' experience and we can assist with relocation costs.Position Description:The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. 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.Position Requirements:BS in a Computer Science or Engineering field or equivalent experienceMinimum 2-4 years' experience with Computer systems validation in the USAMinimum 2 years' experience working in a GMP environmentExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desiredExperience in biotech and pharma is preferred over medical deviceExperience 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, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.Requirements include:Other Requirements:Excellent oral and written communication skills in EnglishAble to travel domestically and internationally as requiredAble to work (paid) overtimeAble 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 employmentAbout CAICAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to 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. 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.#LI-MV1We 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).

Keywords: CAI, Minneapolis , Computer System Validation Engineer Staff 2, IT / Software / Systems , Minneapolis, Minnesota