CQV Engineering Lead
- Employer
- Iovance Biotherapeutics, Inc.
- Location
- Philadelphia, PA
- Start date
- Sep 19, 2019
View more
- Discipline
- Engineering, Process Engineer, Quality Engineer, Science/R&D, Biology, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country
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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
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