Manufacturing Engineer

There are two openings for this role, each with a distinct focus:

• Position 1:Emphasizeschange 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 broadercompliance 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

• 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.

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 not 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