Principal Manufacturing Compliance Engineer

Genentech • Oceanside, CA

2d • Onsite

About The Position

This role is a vital part of our Manufacturing team at Genentech Oceanside, which is dedicated to delivering high-quality biopharmaceuticals safely and reliably to patients worldwide. As a key technical and compliance leader within this department, you will collaborate closely with cross-functional partners across MSAT, Quality Assurance, Facilities & Engineering, and Compliance. In this collaborative environment, you will drive operational excellence, lead root-cause investigations, and ensure continuous adherence to cGMP standards across our biomanufacturing operations. As a Principal Manufacturing Compliance Engineer, you will serve as a primary technical subject matter expert to manage and resolve complex technical, regulatory, and compliance issues across biomanufacturing operations. You will lead cross-functional problem-solving initiatives, ensure full cGMP compliance, and safeguard production integrity through robust quality systems, investigations, and continuous improvement efforts.

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, alongside 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.

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.

Benefits

• Relocation benefits are approved for this posting.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed in this link.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal