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. Your responsibilities will include owning and investigating deviations, supporting tech transfer and commercial manufacturing, reviewing and approving technical documentation, supporting continuous improvements, and partnering with MSAT, Site Operations, and Quality Assurance to tackle quality issues and improve our compliance standing and understanding.
In addition, you’ll lead operational excellence initiatives to improve processes, solve complex problems, and uphold high standards for safety, quality, and compliance. Your contributions will help ensure our products consistently meet customer and regulatory expectations.
This role centers on broader compliance knowledge, with expertise in inspection strategies, risk assessment, and various compliance programs, such as environmental monitoring, personnel flow, and gowning procedures.
The Opportunity
Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S.
Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and Genentech standards by applying advanced theory, technical principals and expert judgment.
Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership.
Lead and and/or facilitate Root Cause Analysis sessions for more complex issues and serve as a coach and process owner for DMS Event Observer/DO Community within their function on best practices
Be able to act as SME to regulatory agencies
Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines.
Who you are
Engineer: BS/BA in Life Sciences/Engineering preferred, and 0-2 years of experience in the pharmaceutical, 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, biopharmaceutical industry or a combination of education and experience.
Ability to make sound decisions about scheduling, allocation of resources and managing of priorities.
Preferred
Strong oral and written communication skills.
Ability to make sound decisions with minimal supervision.
Possess thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH and European guidelines.
Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Experience in technical writing, such as, creation and revision of Standard Operating Procedures or other technical reports/evaluations is desirable
Work Environment/Physical Demands/Safety Considerations
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
May work with hazardous materials.
Relocation benefits are available for this posting.
The expected salary range for this position based on the primary location of Oceanside, CA is $80,500 (min) - $115,000 (mid) - $149,500 (max) annual. 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 at the link provided below.
Benefits
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.
Skills Required
- BS/BA in Life Sciences or Engineering
- 0-2 years pharmaceutical/biopharmaceutical industry experience (Engineer level)
- 3-7 years pharmaceutical/biopharmaceutical industry experience (Senior Engineer level)
- Ability to make sound decisions about scheduling, resource allocation, and priorities
- Thorough knowledge and understanding of cGMPs
- Familiarity with FDA, ICH and European regulatory guidelines
- Experience leading Root Cause Analysis and implementing CAPA
- Strong oral and written communication skills
- Experience in technical writing (creation/revision of SOPs and technical reports)
- Ability to work in cleanroom environments and wear required PPE (bunny suits, scrubs, gloves, steel-toe boots)
- Willingness/ability to work with hazardous materials as required by duties
Genentech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
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Retirement Support — Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
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Leave & Time Off Breadth — Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.
Genentech Insights
What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.
