As a Commissioning, Qualification, and Validation (CQV) Process Engineer, you will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position shall be responsible for the development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers. Join us and you will have the chance to work on projects including state of the art pharmaceutical facilities.
You’ll be accountable for providing CQV process support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. You will be responsible 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. You will perform risk assessments and impact assessments, participate on integrated delivery (EPCMV) project teams to delivery facility and process, and you will be responsible for applying engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC utilities, instrumentation, controls, and automation to support clients and troubleshoot processes. Additional responsibilities include leading tech transfer projects for clients.
• Bachelor’s degree in Chemical, Mechanical or Electrical Engineering or equivalent years of experience in lieu of degree
• At least 2 years of CQV process engineering experience in the Life Sciences industry
• Understanding of Good Manufacturing Practices (GMPs)
• Strong technical writing skills
• Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
• Flexibility and willingness to travel and work at various clients’ locations
• Ability to work well with diverse, multi-disciplined groups
• Ability to effectively communicate with management and fellow project team members
• Ability to negotiate/compromise with other project team members to achieve project goals
• Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements
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
