Senior Computer System Validation Engineer
Posted on :
23-11-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1766472
Responsibilities:
- Provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.
- Help drive collaboration, exceeding expectations, and challenging the status quo.
- Develop CSV/CQV planning documents to manage CQV projects, generating and executing CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CSV summary reports, and starting up equipment in a safe and effective manner.
- Perform risk assessments and impact assessments.
- Accountable for developing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS, and summary reports.
- Bachelor's degree in Electrical or Computer Engineering or equivalent; Higher Education Preferred
- CSV experience in the Life Sciences industry
- Understanding of Good Manufacturing Practices (GMPs)
- Strong technical writing skills
- Proficient with Microsoft Office Word, Excel, PowerPoint, Project
- Experience with qualifying SCADA, Delta V, Client and Client systems
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
- Six Sigma Certification preferred
- Knowledge of industry guidance a plus:
- ISPE Baseline Guide 5 Commissioning and Qualification
- ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
- ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Employment Type
Full Time
Key Skills
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