Principal Biopharma Manufacturing Compliance Engineer

Roche; Oceanside (CA); On-site; USD 95,000 - 177,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech Oceanside is seeking a Principal Manufacturing Compliance Engineer to lead cross-functional, cGMP-compliance for biomanufacturing operations. You will drive investigations, sponsor CAPA, and act as SME during regulatory inspections, partnering with QA, MSAT, Facilities & Engineering.

Relocation benefits are approved; the role requires a BS/BA in Life Sciences or Engineering with 5+ years in pharma and hands-on quality systems experience; strong RCA, SOP writing, and leadership skills

Qualifications

• Bachelor’s degree in Life Sciences, Engineering or related field with 5+ years in pharma/biopharma.
• Hands-on mammalian cell culture and/or purification experience; thorough cGMP knowledge.
• Proven Deviation Management and CAPA experience.
• Experience leading RCA investigations and writing SOPs and validation reports.
• Strong cross-functional leadership and communication skills.

Responsibilities

• Manage and resolve complex technical, quality, and compliance issues in biomanufacturing with QA, MSAT, and Facilities & Engineering.
• Act as a Discrepancy Owner Lead, coordinating CAPA and RCA within required timelines.
• Perform technical reviews and approvals for process validation protocols, engineering changes, variance reports, and controlled docs.
• Serve as Manufacturing SME to regulatory agencies and during site inspections.
• Identify and mitigate technical or equipment risks affecting production or compliance.
• Mentor manufacturing personnel to foster compliance mindset and ownership.
• Track and present departmental performance metrics and environmental monitoring data.

Skills

cGMP knowledge

RCA investigations

CAPA execution

Regulatory compliance

SOP writing

Process validation

Change control

Quality systems

Leadership

Technical writing

Education

BS in Life Sciences

Engineering degree

Tools

DMS

CAPA system

Job description

Genentech Oceanside is seeking a Principal Manufacturing Compliance Engineer to lead cross-functional, cGMP-compliance for biomanufacturing operations. You will drive investigations, sponsor CAPA, and act as SME during regulatory inspections, partnering with QA, MSAT, Facilities & Engineering.

Relocation benefits are approved; the role requires a BS/BA in Life Sciences or Engineering with 5+ years in pharma and hands-on quality systems experience; strong RCA, SOP writing, and leadership skills