Sr. Process Engineer Sangart
THIS JOB HAS EXPIRED Duties:
Research and interface with vendors to determine secondary source for all critical process equipment (i.e. filters).
Perform development studies pertaining to optimization, formulation, filtration, chromatography, new product development, scale up, etc.
Maintain on-going engineering support for Facilities and Manufacturing groups and cGMP operations, including troubleshooting of equipment/systems, and implementation of improvements to enhance equipment reliability, process throughput, and cost reduction.
Assist with design and implementation of flexible polymer film product container.
Generate, execute, and manage engineering study protocols and reports.
Assist the validation group in the area of change control for validated manufacturing equipment and processes.
Develop and maintain an effective cross-functional working relationship with Manufacturing, Validation, Regulatory, and Quality Assurance to address process deviation investigations and resolution. .
Interface with Manufacturing in developing batch records and standard operating procedures to support the manufacturing process.
Promote cohesive, team-oriented atmosphere within the Operations department and externally via interdepartmental cooperation.
BS in Engineering or Life Science
8+ years of experience working in the pharmaceutical or biotechnology industry
Experience with polymer film for flexible product containers a plus.
Experience with basic laboratory equipment and practices
Working knowledge of cGMP regulations applicable to validation and operation of manufacturing processes and equipment
Ability to analyze and interpret scientific data using basic statistical methods
Good leadership, team-building, interpersonal and written/verbal communication skills
||6175 Lusk Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED