CSV Engineer
CSV Engineer
Posted on :
07-04-2025
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1 Vacancy
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Job Description
We are seeking CSV Engineers with 25 years experience and 2 years experience in GMP environment.
About CAI
CAI is a 100 employeeowned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning qualification validation startup project management and other consulting services associated with operational readiness to FDA regulated and other missioncritical industries.
Meeting a Higher Standard
Our approach is simple; we put the clients 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 persons success is everyones success; we work diligently to accomplish team goals. We place Team Before Self demonstrate Respect for Others and possess a CanDo 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
27 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 PASX 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
La selezione rispetta il principio delle pari opportunit (l. 903/77
#LIAG1
Employment Type
Full-Time
Key Skills
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