CSV Engineer

Company: Jacobs Engineering Group Inc.
Location: Kalamazoo
Posted on: May 3, 2021

Job Description:

Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference.

As a Computer System Validation (CSV) Engineer, you'll join our collaborative team providing CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate CSV Engineer who is driven by collaboration, exceeding expectations, and challenging the status quo.

You'll be accountable for developing 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; as well as performing risk assessments and impact assessments. You'll also be accountable for developing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS, and summary reports.

Bring your curiosity, talent for multi-taskingand collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.

• Bachelor's degree in Electrical or Computer Engineering or equivalent
• 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
• Flexibility and willingness to travel and work at various clients' locations

Ideally, you'll also have:

• Experience with qualifying SCADA, Delta V, BAS and BMS systems
• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance:

oISPE Baseline Guide 5 Commissioning and Qualification

oISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

oASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

oISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011

oISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

• Six Sigma Certification

#LifeSciences #AF

Keywords: Jacobs Engineering Group Inc., Kalamazoo , CSV Engineer, Other , Kalamazoo, Michigan