Senior Manufacturing Engineer - Digital GMP Systems Lead

GeneFab; Emeryville (CA); On-site; USD 110,000 - 145,000; Part time

Benefits offered by this job

Long-term employment opportunities

Innovative work environment

Job summary

GeneFab is seeking a Senior Manufacturing Engineer in Emeryville, California to spearhead the integration of advanced production technologies and digital systems within GMP operations. The role involves ownership of critical equipment and systems, ensuring regulatory compliance, and supporting commercial readiness initiatives.

The ideal candidate will have extensive experience in GMP environments, and will work to innovate processes in a high-impact, fast-paced setting. Opportunities exist for long-term employment based on performance.

Qualifications

• Minimum 8+ years of experience in pharmaceutical, biopharmaceutical, or cell/gene therapy manufacturing environments.
• 3+ years of direct experience with production technology and digital manufacturing systems in a GMP-regulated setting.
• Hands-on experience with equipment data integration including familiarity with OPC-UA, APIs, and middleware platforms.

Responsibilities

• Lead design, selection, and implementation of production technologies for cell and gene therapies.
• Implement electronic batch record platforms to replace paper records.
• Manage equipment lifecycle and ensure compliance with 21 CFR Part 11 and GAMP 5 guidelines.

Skills

GMP manufacturing knowledge

Equipment data integration

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Advanced degree (M.S. or Ph.D.) preferred

Tools

EBR

LIMS

MVIS

AVEVA PI

Job description

GeneFab is seeking a Senior Manufacturing Engineer in Emeryville, California to spearhead the integration of advanced production technologies and digital systems within GMP operations. The role involves ownership of critical equipment and systems, ensuring regulatory compliance, and supporting commercial readiness initiatives.

The ideal candidate will have extensive experience in GMP environments, and will work to innovate processes in a high-impact, fast-paced setting. Opportunities exist for long-term employment based on performance.