The Bergaila Companies

Computer System Validation Engineer (CSV) - 20041

Posted Date 5 days ago(12/1/2022 9:49 AM)
Job ID
2022-9227
Location : City
Indianapolis
Location : State/Province
IN

Overview

We are seeking a Computer System Validation Engineer for a contract-to-direct assignment in Indianapolis, Indiana. The selected candidate will  provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.

 

Hours are Monday - Friday, 8:00am - 4:30pm

 

** This position is on-site **

** This position pays $55 - $64/hr **

** This position will be on a W2 **

Responsibilities

- Develop CSV/CQV planning documents to manage CQV projects

- Generate and execute CSV/CQV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)

- Investigate and resolve protocol exceptions or discrepancies

- Develop technical reports and CSV summary reports

- Startup equipment and systems in a safe and effective manner

- Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports

- Perform risk assessments and impact assessments

Qualifications

- Bachelors Degree in Electrical or Computer Engineering

- CSV experience in the Life Sciences Industry

- Understanding of Good Manufacturing Practices (GMPs)

- Technical writing skills

- Experience with qualifying SCADA, Delta V, BAS and BMS systems is highly preferred

- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations is highly preferred

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