Process Development Engineer I

Title: Process Development Engineer I

Pay: $35.00-$40.75/hr

Location: San Diego, CA - Onsite

Duration: 13-month contract

Schedule: 8:00 AM-5:00 PM

Overview

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

Key Responsibilities

• Provide technical guidance in the production and analysis of oligonucleotides in a regulated manufacturing environment.
• 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.
• 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.
• Apply change management practices to drive improvements in safety, quality, efficiency, and cost.
• Support the transfer of manufacturing processes between manufacturing locations.
• Maintain productive cross-site and cross-functional relationships.
• Execute manufacturing builds as needed to support development, pre-production, and production orders.
• Plan and prioritize assigned tasks and activities with minimal guidance.
• Execute tasks independently, with guidance from the project lead or manager as needed.
• Influence technical decisions within the assigned area of responsibility.
• Track component cost of goods sold (COGS) and associated project expenses.

Qualifications

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

Education and Experience

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