We are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.
About CAI
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.
CAI agents 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 market. 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 customers benefit from exemplary work across our entire range of professional services.
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 experience
2-7 years’ experience with Computer systems validation
2 years’ experience working in a GMP environment
Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience 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, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
#LI-AG1
Top Skills
What We Do
Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
We are 800+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location.
Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance.
When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.
