You’ll be accountable for developing CQV planning documents to manage CQV projects, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CQV summary reports, and starting up equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You’ll also be accountable for reading and verifying facility and equipment drawing (e.g., P&IDs, AF&IDs, etc.), developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.
• Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree
• 2+ years of CQV experience in the Life Sciences industry preferred
• Understanding of Good Manufacturing Practices (GMPs)
• Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
• Flexibility and willingness to travel and work at various clients’ locations
Ideally, you’ll also have:
• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification
o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
• Six Sigma Certification
