CQV Engineering Lead

The Commissioning, Qualification and Validation (CQV) Engineer will lead the CQV effort to support the development of a commercial scale CGMP cell therapy manufacturing facility. This position shall be responsible for the development and execution of CQV testing and documentation for a variety of equipment, utilities, components, products, and systems for a cell therapy manufacturer as well as leadership of the project CQV team.

Technical/Functional Responsibilities:

• Lead the CQV function for a major cGMP capital project
• Develop and implement safety programs for CQV functions on a major capital project.
• Develop CQV planning documents to manage CQV projects including CQV plans and protocols.
• Generate and execute CQV protocols using Good Documentation Practices (GDPs)
• Investigate and resolve protocol exceptions or discrepancies
• Develop technical reports and CQV summary reports
• Startup equipment in a safe and effective manner
• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.).  Perform or facilitate design qualification
• Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation
• Perform risk assessments and impact assessments
• Perform factory acceptance test on critical systems and process equipment.
• Develop scope of services for CQV contractors.  Participate in the bidding process for these services including evaluation of proposals and recommendation for award.
• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support the project
• Develop and implement training programs for CQV personnel.

Minimum Qualifications:

• BS in Life Sciences or equivalent
• 10+ years of successful CQV experience in the pharmaceutical or biotech industry including CQV leadership positions on major cGMP capital projects
• Demonstrable experience creating and utilizing systems for monitoring and controlling the execution of CQV functions on a major capital project.
• Demonstrable experience managing CQV teams of both internal and contracted personnel
• Strong experience developing and executing CQV protocols for single-use process systems in a CGMP environment
• Demonstrable experience creating and maintaining CQV policies, processes and procedures for a new cGMP facility
• Demonstrable experience utilizing risk-based assessments as outlined in ASTM E2500 and setting up lifecycle verification programs for manufacturing systems.
• Strong understanding of and experience with project control systems including scheduling and budget control and forecasting tools.
• Ability to effectively communicate with management and project team members