Senior Process Engineer

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.

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