Validation Engineer (Medical Device and IT Systems)
Commissioning Agents, Inc. - Chicago, IL

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We are looking for Validation Engineers with Medical Device and Software Validation experience in the midwest for our growing practice.

Commissioning Agents, Inc is an Employee Owned Company (ESOP). We take pride in the services that we offer to our clients, and have established a reputation of excellence within our industry.

Our compensation package rewards you for the skills and value you contribute to the success of our organization. As a global service provider, we offer the opportunity to travel and work with various cultures. We also value a work/life balance, and as life takes its course, we can work with you to find a desirable city or region that best fits your personal goals.

We are currently hiring in Indiana, Illinois, Ohio and Missouri with other states in consideration as well . The ideal candidate will have 1-8 years experience in some of our core service areas and be interested in learning the rest.

Commissioning

· Requirements development

· Planning and schedule development

· Design and submittal reviews

· Pre-delivery inspections

· Factory and site acceptance (FAT/SAT) support

· Equipment receipt and installation inspections

· Construction quality oversight/ in-process inspections

· Execution coordination/ management

· System start-up/ shakedown / troubleshooting

· Functional and performance testing

· DCS, BAS/ BMS, and PLC Installation Checkout

Validation

· Process validation

· Cleaning validation

· Sterilization validation

· Master plans

· IT Systems Validation

· Automation validation

Qualification

· Protocol execution

· Facilities, utilities, process equipment

· IQ/OQ/PQ protocol development

· Final reports

· Lab equipment

Commissioning Agents, Inc. (CAI) provides integrated validation, qualification and commissioning services for technology intensive capital projects and building construction. Our services include validation and commissioning planning, management, and field execution for biotech/pharmaceutical manufacturing facilities and laboratories, and Building Commissioning and LEED Cx services for educational, healthcare, government and private facilities, and data centers. We also provide regulatory compliance consulting, maintenance program development, SOP and training development, and computer software development and validation.

Qualified candidates must be legally authorized to be employed in the United States. CAI does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


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