Senior Process Engineer

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.

How You’ll Contribute

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

Qualifications, Skills, Knowledge Abilities

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

At Ultima Genomics, your base pay is one part of your total compensation package. This role pays between $110,000 and $130,000, if performed in California, and your actual base pay will depend on your skills, qualifications, experience, and location. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes: medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending health savings account; paid holidays; paid time off; employee assistance program; and other company benefits.

#LI-Onsite

Ultima Genomics is proud to be an equal opportunity workplace and is an affirmative action employer. We provide equal employment opportunity for all applicants and employees. We do not discriminate on the basis of race, color, religion, sex…