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.
- 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
On Assignment - 2 years ago