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.
Requirements include:
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
5+ 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
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.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future
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.
Benefits
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.
#LI-MV1
...Summary Safely operates a heavy-duty truck to perform assigned duties on designated... ...assigned vehicle using utilizing standard DVIR (Driver Vehicle Inspection Report); notes all... ...perform the job. A. Education and Experience Education: None required. Experience...
Senior Technician - Fridley, MN Intertek, a leading provider of quality and safety solutions to many of the world's top-recognized brands and companies, is actively seeking a Senior Technician to join our Building & Construction team in Fridley, MN . This ...
Innovate to solve the world's most important challenges The future is what you make it. When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future. That means changing the...
JOB DESCRIPTION: $85K-$280K SEEKING COMMERCIAL PAINT PROJECT MANAGER/ESTIMATOR GPAC: #1 Commercial Paint Recruiting Firm in the Nation: WORK FOR A LEADING CONTRACTOR I am working with a well-respected, firmly established Commercial Paint Contractor seeking an experienced...
...Regional Truck Driving Job Based Out of Bakersfield, CA We are now hiring CDL-A drivers for a refrigerated OTR regional driving job based out of Bakersfield, CA. This lane operates within the Western region, offering home time every two weeks. Position Details:...