Computer Systems Validation IT Engineer
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Accentuate Staffing is partnering with a Biotech/Pharmaceutical company that is looking to hire a Computer Systems Validation (CSV) IT Engineer to coordinate computer system validation projects with Quality and IT teams. To be considered for this position, you’ll need experience ensuring compliance with federal regulations and corporate policies and procedures for computerized systems in the Life Sciences (pharmaceutical/biotech) Industry.
We’re looking for someone interested in a full-time opportunity with great benefits, a competitive salary, and local to the Morrisville, NC area. If you’re looking to join a collaborative and patient-focused organization that has the goal of bringing novel therapies to patients who need them the most, this is the opportunity for you.
Responsibilities:
- In this position, you will initiate, implement, and oversee validation activities regarding compliance with internal controls and CGMP, GAMP, and 21 CFR Part 11 practices for computer systems.
- You’ll work with SMEs to prepare and execute protocols, test scripts, periodic reviews, and the creation of documentation like assessments, plans, and summary reports.
- Work with Operations, Quality, and IT teams by assessing the risk and impact of proposed changes to validation processes and within the facilities to maintain systems in a validated state.
- Work on communication systems deployment, cloud vendor management, and integration, server and network infrastructure growth, and security-related program/system projects.
Requirements:
- 5 years of experience in computerized system validation and IT infrastructure systems administration
- IT infrastructure knowledge and a risk-based approach to ensure product quality.
- Experience networking – VLANs, WiFi, and network segmentation
- Experience writing GxP computer validation and 21 CFR Part 11 related documentation such as URS, FRS, and RTM.
