Senior Process Engineer

Ultima Genomics•Fremont, CA

1d•$110,000 - $130,000•Onsite

About The Position

Rapidly Growing Life Sciences Technology Company Ultima Genomics is a rapidly growing company that is developing ground-breaking genomics technologies. Our mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. We have developed a foundational new approach to sequencing at scale that overcomes limitations due to the high costs of current technologies. We are well-funded and have raised approximately $600 million from global top-tier investors. Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond. We are a collaborative group, including successful entrepreneurs, chemists, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Join us to develop and commercialize technologies that unleash the power of genomics at scale and empower the future of human health. We are looking for a highly motivated Senior Process Engineer to join our team! As a Senior Process Engineer, you will focus on optimizing and scaling manufacturing processes for DNA sequencing reagents and consumables to improve yield, efficiency, and reliability while supporting new product introduction and lifecycle activities. It involves cross-functional collaboration to troubleshoot issues, drive continuous improvement, and ensure adherence to regulatory and quality standards. This is a full time onsite position at our Fremont, CA location.

Requirements

Degree in Bioengineering, Chemical Engineering, or related field
BS with 5+ years or MS with 3+ years of related industry experience in process engineering, consumable manufacturing, or a related environment
Familiar with PLM systems and BOM management
Experience with scale-up of chemical formulations (500+ liter scale)
Experience working in or supporting regulatory environments (ISO 13485 preferred)
Hands-on mindset with the ability to work both on the production floor and in documentation systems
Strong analytical and problem-solving skills
Excellent communication and cross-functional collaboration abilities
Ability to work in a fast-paced environment with a proactive, self-starting attitude

Responsibilities

Identify and implement process improvements to increase yield, throughput, and reliability of DNA sequencing reagents and consumables
Author, review and maintain process documentation, including Standard Operating Procedures (SOPs), Bills of Materials (BOMs), and Product Lifecycle Management (PLM) records for reagents, consumables, and packaging
Collaborate with R&D and Operations to scale up reagent formulations from development to production at volumes exceeding 500 liters
Design, develop, and qualify manufacturing and quality control tools and equipment to support production, including foil sealers, desiccator testing, basic inspection tools such as vernier heigh gauge, calipers and dial indicators
Design and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for production equipment
Analyze production data using Statistical Process Control (SPC) to identify trends, troubleshoot issues, and drive continuous improvement initiatives
Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective and preventative actions (CAPA)
Support cost-reduction efforts through process optimization, material selection, vendor qualification, and workflow improvements
Support NPI/NPT for reagent products and packaging
Act as the manufacturing technical liaison to R&D, Quality, Regulatory, Supply Chain, and site leadership teams, ensuring the complete product lifecycle is considered in all decision making
Ensure adherence to regulatory requirements and company standards across all activities
Other job duties as assigned