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NextGen Person

Computer Systems Validation Engineer in Kalamazoo, MI at NextGen

Date Posted: 2/11/2019

Job Snapshot

Job Description

Computer Systems Validation Engineer - ( Systems related to Manufacturing / Process Equipment)

1 Year contract to start

Kalamazoo, MI 49001

8am - 5pm

M-F

****Looking for a Validation Engineer experienced on aseptic fill lines and their associated equipment. Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation controls, and automation to support clients

Responsibilities:

  • Provide Computer System Validation (CSV) /CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices
  • Develop Computer System Validation planning documents to manage CQV projects (VMP, FRS, DQ)
  • 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

Qualifications:

  • Experience with Aseptic Fill Line Equipment (Autoclave, Washer, Filler, Freeze Dryer, Tray Loader, etc)
  • Experience with Data Integrity
  • Experience with qualifying SCADA systems
  • Experience with qualifying BAS and BMS system
  • 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

Qualifications:

  • BS Electrical or Computer Engineering or equivalent
  • 4-12 years of Computer System Validation 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