Biopharma Compliance Engineer: cGMP, CAPA & Tech Transfer

Genentech; Oceanside (CA); On-site; USD 81,000 - 150,000; Full time

Benefits offered by this job

Relocation benefits available

Discretionary annual bonus

Job summary

Genentech is seeking an engineer to join the Oceanside team to resolve technical and compliance issues across Quality, Technology, and Operations while maintaining cGMP and SOP standards. You will review documentation, support tech transfer, and drive continuous improvement with cross-functional partners to ensure regulatory compliance and product quality.

The role emphasizes strong communication, risk assessment, and the ability to lead Root Cause Analysis sessions, with relocation benefits

Qualifications

• BS/BA in Life Sciences/Engineering preferred.
• 0–2 years experience for Engineer level or 3–7 years for Senior Engineer in pharmaceutical/biopharmaceutical industries.

Responsibilities

• Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S.
• Lead Root Cause Analysis sessions for complex issues and serve as coach for DMS Event Observer/DO Community.
• Act as SME to regulatory agencies and support CAPA implementation per timelines.
• Support tech transfer and commercial manufacturing while maintaining quality system records and regulatory compliance.

Skills

Life Sciences/Engineering background

Regulatory compliance knowledge

Analytical decision-making

Education

BS/BA in Life Sciences/Engineering

3-7 years pharma/biopharma experience

Job description

Genentech is seeking an engineer to join the Oceanside team to resolve technical and compliance issues across Quality, Technology, and Operations while maintaining cGMP and SOP standards. You will review documentation, support tech transfer, and drive continuous improvement with cross-functional partners to ensure regulatory compliance and product quality.

The role emphasizes strong communication, risk assessment, and the ability to lead Root Cause Analysis sessions, with relocation benefits