Manufacturing Engineer

Genentech

11h

About The Position

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 reviewing and approving technical documentation, supporting the design and validation of processes and equipment, and partnering with MSAT, Compliance, and Quality Assurance to tackle quality issues.

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.
There are two openings for this role, each with a distinct focus:
Position 1: Emphasizes change control experience, focusing on duties as a Change Record Owner. This includes managing planned event processes and associated documentation while ensuring regulatory compliance.
Position 2: 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.

Requirements

• BS/BA in Life Sciences/Engineering preferred, and at least 5 years’ 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.
• 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.

Nice To Haves

• Strong oral and written communication skills.
• Ability to make sound decisions with minimal supervision.
• Experience in technical writing, such as, creation and revision of Standard Operating Procedures or other technical reports/evaluations is desirable

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees