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Hydrogen Group

Process Development Engineer I

la jolla shores, CA

Check who can apply and the requirements below before continuing.

About this opportunity

Hydrogen Group lists this Process Development Engineer I opportunity in la jolla shores, California. Review the employer’s description below for duties, qualifications and application requirements.

Job description

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.

Who can apply

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