Principal 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

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.

The Opportunity

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.

• 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.

Who You Are

• Education & Experience: 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).

• Technical Expertise: 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.

• Quality Systems Mastery: Proven expertise in Deviation Management Systems (DMS) as a Discrepancy Owner, including proficiency with CAPA execution and Change Control processes.

• Problem Solving & Technical Writing: 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.

• Leadership & Communication: Strong written and oral communication skills, with a track record of driving cross-functional alignment, prioritizing assignments independently, and mentoring teams under minimal supervision.

This is an on-site position.

Relocation benefits are approved for this posting.

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. This position also qualifies for the benefits detailed in this link.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.