We are seeking a skilled professional to partner with our clients in the Pharmaceutical and Biotechnology Manufacturing sector. The ideal candidate will have expertise in developing and executing protocols, test scripts, and validation documentation.
* Develop and execute protocols and test scripts to identify gaps and consult on plans for resolution.
* Create GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
In order to succeed in this role, you will need:
* A Bachelor's degree in Computer Science or Engineering or equivalent experience.
* 1-3 years of experience in Computer systems validation.
* At least 1 year of experience working in a GMP environment.
* Strong knowledge of Data Integrity with GAMP and 483 compliance consent decree experience, as well as deep 21 CFR Part 11 experience is highly desirable.
* Experience in biotech and pharma is preferred over medical device.
* Mastery of MES Delta V PI is a significant plus.