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.
