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CSV Engineer (Contract - MI)

Company: Compri Consulting, Inc.
Location: Kalamazoo
Posted on: June 14, 2019

Job Description:

Compri Consulting's client is seeking a CSV Engineer for a 7-month contract opportunity in Kalamazoo, MI.Duties Provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices: Develop CSV/CQV planning documents to manage CQV projects Generate and execute CSV 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 Apply engineering knowledge of, aseptic processing equipment and its associated automation to support project needs. Required Skills The ideal candidate for this position will possess the following: Experience with qualifying SCADA systems BS Electrical or Computer Engineering or equivalent 4 -14 years of CSV experience in the life sciences industry Understanding of Good Manufacturing Practices (GMPs) Technical writing skills Proficient with Microsoft Office - Word, Excel, PowerPoint, Project Ability to work well with diverse, multi-disciplined groups Ability to effectively communicate with management and fellow project team members Ability to negotiate/compromise with other project team members to achieve project goals Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements Preferred Skills Experience with qualifying SCADA systems Six Sigma Certification Computer System Validation Experience with respect to Aseptic Fill Lines and their associated equipment Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations Knowledge of industry guidance: 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 Compri Consulting has been excelling in IT solutions since 1992. We firmly believe in the importance and value of people and personal relationships. Our organized and unique approach has yielded quality results time after time. For additional Compri job opportunities, please check out

Keywords: Compri Consulting, Inc., Kalamazoo , CSV Engineer (Contract - MI), Engineering , Kalamazoo, Michigan

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