Senior Process Engineer
Lab Support - San Diego, CA

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This is a direct hire opportunity offering a competitive salary and great benefits for a well known biotech company in San Diego. We are currently seeking a Sr Process Engineer to join this dynamic team!

Description of 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.
Responsibilities:
  • 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.
Job Qualifications:
  • 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

On Assignment - 18 months ago - save job - block
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