Sr. Process Engineer
BioPhase Solutions - San Diego, CA

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BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Process Engineer to work for a leading San Diego biotechnology company.

Sr. Process Engineer

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.

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

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