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.
Requirements:
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
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