Validate computer systems for life sciences companies.
Key Responsibilities:
* Develop and execute protocols and test scripts to identify gaps, consult on, and direct plans for resolution.
* Write GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Requirements:
* Bachelor's degree in Computer Science or Engineering field or equivalent experience.
* 1-3 years of experience with Computer systems validation.
* 1 year of experience working in a GMP environment.
* Data Integrity experience with GAMP and 483 compliance consent decree experience deep 21CFR Part 11 experience is a plus.
* Experience in biotech and pharma is preferred over medical device.
* Experience with MES Delta V PI is a plus.
We Utilize:
* Rockwell
* GE
* Emerson
* ABB
* Werum
* Siemens
* Honeywell
* PAS-X
* Syncade
* FactoryTalk
* PharmaSuite
* Control Logix
* PLM
* Simatic
* iFix
* Wonderware