Validation Specialist for Computer Systems and Software
7 days ago
We are seeking a skilled Validation Specialist to coordinate validation efforts for computer systems, hardware, and software in our lab setting. This role is responsible for ensuring process quality and compliance with GxP, GAMP, and Code of Federal Regulations.
Estimated Salary: $95,000 - $120,000 per year
About the Job- This salaried position involves managing computer validation project activities, creating planning documents and testing protocols, and reviewing test results to identify areas for improvement.
- The successful candidate will provide technical expertise to team members and other departments while communicating the validation plan and creating protocols.
- Work with QA management to develop and implement an efficient software/computer validation program for a GLP environment.
- Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments with external teams.
- Partner with business and validation teams for site computer validation projects.
- Develop software/validation protocols and final reports, as well as coordinate and perform activities per protocols.
- Maintain the site Master Validation Schedule and periodically review validated systems.
- Assist QA in auditing vendors of cGMP-related software and hardware.
- Evaluate vendor validations and add company-specific protocols as required to complete validation.
- Provide technical counsel on issues and concerns regarding validation plans and protocol designs.
- Train company staff as needed on SOPs.
- Bachelor's degree or equivalent.
- 5-10 years of experience in Computer System Validations.
- Knowledge of GxP.
- Advanced understanding of laboratory operations and data collection.
- Ability to work effectively under time constraints.
This role involves approximately 80% office work and 20% laboratory work, exposing you to animal pathogens and chemicals. You will need to don personal protective gear, including N95 masks and respirators, and have the ability to lift and carry up to 50lbs. Occasional ladder and stair use may be required.
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