King of Prussia, PA30+ days ago
CSV Engineer: A minimum of four years of computer system validation experience in the pharmaceutical, biotech, medical device or other FDA regulated industries, Competency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessments Experience in generating software development life cycle documentation such as FRSs, SDSs, HDSs and configuration specifications Hands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software platform An understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipment. Technical Skills & Qualifications: • Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree) • Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities • Strong technical writing and oral communication skills • Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD) • Experience with entire project lifecycle from concept development through startup (preferred).