Senior Process Engineer (Life Sciences)

TL;DR

Senior Process Engineer (Life Sciences): Optimizing and scaling manufacturing processes for DNA sequencing reagents and consumables with an accent on yield, efficiency, and reliability. Focus on scaling chemical formulations to 500+ liter volumes, implementing Statistical Process Control (SPC), and ensuring strict regulatory compliance.

Location: Onsite in Fremont, California, United States

Salary: $110,000 – $130,000

Company

hirify.global is a rapidly growing life sciences technology company developing groundbreaking genomics sequencing technologies to enable advances in biology and human health.

What you will do

• Implement process improvements to increase yield, throughput, and reliability of sequencing reagents and consumables.
• Author and maintain critical process documentation, including SOPs, BOMs, and PLM records.
• Scale up reagent formulations from R&D to production volumes exceeding 500 liters.
• Design, develop, and qualify manufacturing tools, executing IQ, OQ, and PQ protocols.
• Analyze production data using SPC to identify trends and drive continuous improvement.
• Act as the manufacturing technical liaison for R&D, Quality, Regulatory, and Supply Chain teams.

Requirements

• Degree in Bioengineering, Chemical Engineering, or a related field.
• BS with 5+ years or MS with 3+ years of industry experience in process engineering or consumable manufacturing.
• Experience with scale-up of chemical formulations (500+ liter scale).
• Familiarity with PLM systems and BOM management.
• Experience working in regulatory environments, ISO 13485 preferred.
• Must be based in or able to work onsite in Fremont, CA.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability insurance.
• 401(k) retirement plan.
• Flexible spending and health savings accounts (FSA/HSA).
• Paid holidays and paid time off.
• Employee assistance program.