CQV Engineer

Baltimore, Maryland

Title:  CQV Engineer; level dependent on experience/qualifications

Location:  Baltimore, MD area

 

Position Description

  • Manage and/or provide project support to complete commissioning and qualification activities starting as early as conceptual design through operational readiness.
  • Generate commissioning and qualification protocols for biopharmaceutical equipment, downstream processing equipment, multiple types of compounding equipment, integrated fill finish machines, clean and dirty utilities, controlled temperaturechambers, and laboratory equipment.
  • Ability to conduct field inspections including piping and equipment walk downs, operational startup, and troubleshooting.
  • This person is responsible for protocol execution, field verification and generation of summary reports at the client site.
  • Subject matter expert and experience in either biotech, aseptic fill finish, OSD or clean utilities (WFI, clean steam, PW, Nitrogen, CIP, SIP, etc).
  • Be familiar with Microsoft software for document handling such as Word, Excel, PowerPoint, Visio, Project etc.
  • Develop and manage productive working relationships with project team members and stakeholders, including client staff, vendors, etc. 

Minimum Requirements/Qualifications

  • Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering or equivalent.
  • Minimum 3 years of experience in commissioning and qualification in the pharmaceuticalindustry.
  •  Experience with Single Use Technology/Single Use Mixers, Bioreactors, TFF Skids, UF Skids, and other GMP equipment (desired).
  • Ability to review and interpret design documents and engineering documents.
  • Strong written and verbal communication skills.
  • Technical background in the life sciences industry, specifically biopharmaceuticals.
  • Understanding of Good Manufacturing Practices (GMPs)
  • 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, etc.).
  • Willingness to travel a plus.

Ready to Apply? Please submit resumes to hr@a-bio.com