Principal Process Engineer
The Principal Process Engineer supports manufacturing processes and techniques utilized for the production of vaccines and biologics manufactured at industrial sites for a Life Sciences leader. This includes design and control of process unit operations, working with staff to develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation and serving as an SME for development and validation, health authority inspections, and investigations. Specific duties include:
Conduct process design of upstream processes, products and as well as continuous improvements efforts.
Lead planning of engineering, investigational, definition and process validation runs.
Document and interpret study results with recommendations
Provide technical leadership as an subject matter expert in manufacturing and quality operations
Develop and execution of training programs for appropriate audiences
- BS in Engineering with 8 plus years industrial experience including upstream process unit operation design typically used in biotech / vaccine manufacturing
- Knowledge of computer software common to modeling and simulation of biotech manufacturing unit operations and processes
- Proficient with structured methodologies such as GMP,GEP, Quality by Design, Design Space, & Process Control Strategies to be employed in industrial process design, validation and control.
- Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
- Experience in equipment start-up, qualification and validation is preferred
Azzur Group is a growing private company offering GxP compliance consulting and staffing services dedicated to helping life sciences companies succeed. Our experienced staff specializes in manufacturing systems & equipment design, installation & startup, commissioning, and verification/qualification, computerized systems validation, and process validation. Azzur also offers GxP compliance and audit services related to regulatory inspection prep and inspectional finding remediation as well as general project management support. We are continuously updating and maintaining our knowledge base with the latest regulatory requirements, industry best practices, and inspectional trends to help our clients stay ahead.
Fri, 31 Mar 2017 07:26:49 PDT