Manufacturing Compliance Engineer/Senior Manufacturing Compliance Engineer

About the Role

Join our Oceanside team and take on a meaningful role at the heart of biochemical manufacturing. You’ll collaborate across teams to resolve challenges, maintain quality system records, and ensure compliance with regulatory standards using cGMP and SOPs.

• Own and investigate deviations, support tech transfer and commercial manufacturing.
• Review and approve technical documentation.
• Support continuous improvements and partner with MSAT, Site Operations, and Quality Assurance to tackle quality issues and improve compliance.
• Lead operational excellence initiatives to improve processes, solve complex problems, and uphold high standards for safety, quality, and compliance.
• Apply broader compliance knowledge, including inspection strategies, risk assessment, and compliance programs such as environmental monitoring, personnel flow, and gowning procedures.

Responsibilities

• Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration, and EH&S.
• Solve complex issues impacting multiple functions following cGMP regulations and Genentech standards.
• Troubleshoot and direct the resolution of Quality issues through effective interdepartmental and cross-functional partnerships.
• Lead and facilitate Root Cause Analysis sessions for complex issues; serve as a coach and process owner for DMS Event Observer/DO Community.
• Act as a Subject Matter Expert (SME) to regulatory agencies.
• Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines.

Requirements

• Engineer: BS/BA in Life Sciences/Engineering preferred, and 0-2 years of experience in the pharmaceutical or biopharmaceutical industry or a combination of education and experience.
• Senior Engineer: BS/BA in Life Sciences/Engineering preferred, and 3-7 years of experience in the pharmaceutical or biopharmaceutical industry or a combination of education and experience.
• Ability to make sound decisions about scheduling, resource allocation, and priority management.
• Thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH, and European guidelines.
• Experience managing complex assignments requiring independent action and a high degree of initiative.
• Preferred: Strong oral and written communication skills, ability to work with minimal supervision, and experience in technical writing (e.g., SOPs or technical reports).

Work Environment

• Gowning required: hospital scrubs, bunny suits, gloves, and steel-toe boots.
• Work in a cleanroom environment with large mechanical equipment, piping, and pumps connected to tanks serviced by high-pressure steam, water, and air, creating a loud environment.
• May work with hazardous materials.
• Relocation benefits are available.

Pay

The expected salary range for this position in Oceanside, CA is $80,500 - $149,500 annually. 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.

Benefits

This position qualifies for the benefits detailed at Genentech’s benefits link.