Process Development Engineer I

Hydrogen Group; San Diego (CA); On-site; USD 48,000 - 56,000; Full time

Job summary

Hydrogen Group seeks a Process Development Engineer I to support oligonucleotide production, process development, and transfer in a regulated manufacturing environment. The role emphasizes delivering technical guidance, cross-functional collaboration, and process improvements in GMP settings.

The position requires a bachelor’s or master’s in a related field with 2 years of experience, familiarity with LC-MS, chromatography, and ERP systems.

Qualifications

• Bachelor’s or Master’s degree in a relevant field plus two years of related experience.
• Experience in GMP environments and standard laboratory practices.
• Strong analytical, problem-solving, troubleshooting and root-cause analysis skills.
• Experience with SAP or an equivalent ERP system.
• Knowledge of organic synthesis, chromatography, LC-MS and NMR is desirable.

Responsibilities

• Provide technical guidance in production and analysis of oligonucleotides in a regulated manufacturing environment.
• Collaborate with cross-functional teams to resolve production issues; develop and transfer new processes and products; improve existing ones.
• Represent Operations in cross-functional meetings to ensure quality, continuity, and efficiency of transfers.
• Apply change management practices to improve safety, quality, efficiency, and cost.
• Support transfer of manufacturing processes between locations.
• Maintain cross-site and cross-functional relationships.
• Execute manufacturing builds to support development, pre-production, and production orders.
• Plan and prioritize tasks with minimal guidance; work independently with project lead guidance as needed.
• Influence technical decisions within the assigned area of responsibility.
• Track COGS and project expenses.

Skills

Organic synthesis

Automated synthesis

Chromatography

LC-MS

NMR interpretation

GMP experience

ERP SAP

Data analysis

Problem solving

Communication

Education

Bachelor's or Master's degree in relevant field

Preferred fields: Organic Chemistry, Chemistry, Molecular Biology, Biochemistry, Chemical Engineering, Biochemical Engineering

Tools

LC-MS

NMR equipment

Automated synthesis equipment

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.