Manufacturing Engineer II - Front Line Engineering (Biopharmaceutical Manufacturing)

Location: Fully site-based in Vacaville, California, United States

Salary: $93,000–$155,000 annual base salary, plus a performance-related bonus

Company

hirify.global operates more than 30 sites across five continents and manufactures medicines for the life sciences sector through globally connected teams.

What you will do

• Act as the floor-level technical owner and subject matter expert for upstream manufacturing and support systems, including media preparation, clean-in-place, washers and autoclaves, seed train operations, bioreactors, PAT, and harvest/centrifuge systems.
• Triage, troubleshoot, and resolve mechanical, electrical, and automation equipment failures, escalating complex or recurring breakdowns to senior engineering.
• Lead root cause analyses for complex operational events using 5 Whys, Ishikawa, Kepner-Tregoe, and FMEA methodologies.
• Monitor equipment performance, analyze operational data, identify trends, and improve reliability, uptime, and throughput.
• Implement equipment upgrades, modifications, and process improvements through formal engineering change control.
• Support capital projects and technology transfers through URS development, design reviews, and IQ/OQ commissioning and qualification; provide scheduled 24/7 on-call technical support.

Requirements

• Bachelor of Science degree in Engineering or a related field.
• Sound knowledge of GMP requirements for biopharmaceutical manufacturing facilities and operations.
• Strong technical understanding of common biopharmaceutical drug substance manufacturing unit operations; operational experience is preferred.
• Formal root cause analysis training and significant experience leading RCA investigations.
• Excellent interpersonal, communication, writing, problem-solving, and teamwork skills.
• Proficiency with Microsoft Office, SAP, and P&IDs, plus data trending, analysis, reporting, and visualization skills.
• Proven experience managing and executing small- to medium-sized projects.

Culture & Benefits

• In-person collaboration in a site-based manufacturing environment focused on technical precision, quality, and safety.
• Medical, dental, and vision insurance.
• 401(k) matching plan, life insurance, and short- and long-term disability insurance.
• Employee assistance programs and paid time off.
• Performance-related bonus.