Principal Manufacturing Compliance Engineer

About the role

This role is a vital part of our Manufacturing team at Genentech Oceanside, dedicated to delivering high-quality biopharmaceuticals safely and reliably to patients worldwide. As a key technical and compliance leader, you will collaborate closely with cross-functional partners across MSAT, Quality Assurance, Facilities & Engineering, and Compliance to drive operational excellence, lead root-cause investigations, and ensure continuous adherence to cGMP standards across our biomanufacturing operations.

Responsibilities

• Manage and resolve complex technical, quality, and compliance issues in biomanufacturing in close partnership with Quality, MSAT, and Facilities & Engineering.
• Act as a Discrepancy Owner Lead, leading Root Cause Analysis (RCA) sessions and coordinating corrective and preventative action (CAPA) implementations within required timelines.
• Perform critical technical and operational reviews and approvals for process validation protocols, engineering changes, planned/unplanned variance reports, and controlled documentation.
• Serve as a Manufacturing Subject Matter Expert (SME) to regulatory agencies and contribute strategically during site inspections.
• Identify and mitigate technical, procedural, or equipment risks—including microbial contamination risks in cleanroom environments—that could impact production or compliance.
• Drive operational excellence initiatives and mentor manufacturing personnel to foster a strong compliance mindset and operational ownership across the site.
• Track, analyze, and present departmental performance metrics and environmental monitoring data to promptly address adverse trends.

Requirements

• Bachelor’s degree (BS/BA) in Life Sciences, Engineering, or a related field with at least 5 years of experience in the pharmaceutical or biopharmaceutical industry (or an equivalent combination of education and experience).
• Direct, hands-on experience with mammalian cell culture and/or purification of biopharmaceutical products.
• Thorough working knowledge of cGMPs, FDA, ICH, and European regulatory guidelines.
• Proven expertise in Deviation Management Systems (DMS) as a Discrepancy Owner, including proficiency with CAPA execution and Change Control processes.
• Demonstrated ability to lead complex Root Cause Analysis (RCA) investigations and write or revise high-quality technical documents, including Standard Operating Procedures (SOPs) and process validation reports.
• Strong written and oral communication skills, with a track record of driving cross-functional alignment, prioritizing assignments independently, and mentoring teams under minimal supervision.

Benefits

This position qualifies for the benefits detailed in this link.

Pay

The expected salary range for this position based on the primary location of California is $95,200 - $176,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Relocation benefits are approved for this posting. This is an on-site position.