Title: CQV Engineer; level dependent on experience/qualifications
Location: Baltimore, MD area
- 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.
- 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.