Process Development Engineer I

Job Description

Title: Process Development Engineer I

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Pay: $35.00-$40.75/hr

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Location: San Diego, CA - Onsite

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Duration: 13-month contract

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Schedule: 8:00 AM-5:00 PM

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Overview

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This position supports manufacturing project activities, including oligonucleotide production and analysis, process development and transfer, and operational improvements in a regulated manufacturing environment.

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Key Responsibilities

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• Provide technical guidance in the production and analysis of oligonucleotides in a regulated manufacturing environment.
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• Collaborate with cross-functional teams to resolve production issues related to safety, yield, quality, and throughput; develop and transfer new processes and products to production; and enhance existing processes and products.
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• Represent and advocate for Operations' needs in cross-functional meetings to ensure the quality, continuity, and efficiency of products and processes transferred to and implemented within manufacturing teams.
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• Apply change management practices to drive improvements in safety, quality, efficiency, and cost.
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• Support the transfer of manufacturing processes between manufacturing locations.
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• Maintain productive cross-site and cross-functional relationships.
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• Execute manufacturing builds as needed to support development, pre-production, and production orders.
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• Plan and prioritize assigned tasks and activities with minimal guidance.
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• Execute tasks independently, with guidance from the project lead or manager as needed.
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• Influence technical decisions within the assigned area of responsibility.
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• Track component cost of goods sold (COGS) and associated project expenses.
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Qualifications

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• Manufacturing experience in organic synthesis is highly desirable.
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• Working knowledge and experience with automated synthesis and preparative and analytical chromatography.
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• Experience with LC-MS and the ability to interpret NMR data are desirable.
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• Experience in process support and development within a GMP environment.
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• Strong understanding of GMP and experience with standard laboratory practices.
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• Strong analytical, problem-solving, troubleshooting, and root cause analysis skills.
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• Strong interpersonal, verbal, and written communication skills.
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• Strong attention to detail.
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• Experience with SAP or an equivalent ERP system.
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• Experience working in an ISO 13485 or FDA-regulated environment is desirable.
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Education and Experience

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• Bachelor's or master's degree with two years of related experience.
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• Preferred fields of study include Organic Chemistry, Chemistry, Molecular Biology, Biochemistry, Chemical Engineering, or Biochemical Engineering.
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