Computer System Validation Engineer

Kalamazoo, MI 49007

Posted: 02/22/2019 Industry: Engineering Job Number: 169180 Pay Rate: DOE
  • The Engineer will 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, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients
  • Bachelor’s degree in Electrical or Computer Engineering or equivalent
  • 4-12 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
  • Flexibility and willingness to travel and work at various clients’ locations
  • Ability to effectively communicate with management and fellow project team members
  • Ability to negotiate/compromise with other project team members to achieve project goals
  • 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
  • ISPE Baseline Guide 5 Commissioning and Qualification

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HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.

George Estepp

George Estepp is one of the Lead Recruiters here at HKA Enterprises. He specializes in recruiting for the Operations and Maintenance group and Engineering department. George’s advice to job seekers is "avoid having your resume fall into a black hole after applying by following up with me on your application with a quick phone call, text, or email as listed on the job posting." 

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