Are you passionate about making a tangible impact in the world of biopharmaceutical manufacturing? We are seeking a highly skilled Technical Operations Engineer to join our dynamic, innovative multi-product, large-scale, automated biopharmaceutical facility. In this pivotal role, you will be at the forefront of ensuring safety, compliance, quality, and targeted innovation, driving plant performance and success.

You will spearhead the implementation of groundbreaking technologies and procedures, quickly assessing, evaluating, and addressing GMP discrepancies with immediate corrective actions. You will oversee intra-batch process monitoring, data analysis, and comprehensive reporting. As the first-line support for all manufacturing excursions, you will manage the GMP lifecycle of execution-level process data, conduct unit operation process monitoring and data mining, and offer expert assessments to facilitate meaningful changes and improvements. Additionally, you will have the exciting opportunity to collaborate with scientists and engineers across the Genentech/Roche network, leveraging their expertise to enhance our manufacturing processes and drive innovative solutions.

The Opportunity

 Proven ability to provide on-call technical support for a 24/7 manufacturing operation. This includes being available to respond to requests for assistance from the Manufacturing floor related to automation, equipment or process issues. 

Provide technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment. § Support management of the lifecycle of execution level process data and specifications. 

Assist with batch monitoring through evaluation of targeted production outputs of both routine (trend review, Batch Record information) and atypical nature (e.g. Discrepancies, Out Of Specification) and by providing data analysis, trend reviews and summary data to that activity as part of ongoing plant operations. 

Support implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI). 

Support risk analysis activities aimed at providing the most compliant and robust execution of production at a unit operation level. 

All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.  

Supplementary Responsibilities

Act as Subject Matter Expert for training on process and equipment relevant to plant operations, fostering open communication, teamwork, and transparency.

Gather and analyze data on campaign material consumption, communicate changes for site logistics and planning, and provide solutions to material availability issues.

Serve as Corrective Action and Preventative Action Assignee, support non-routine maintenance activities, and participate in cross-functional projects or teams.

Who you are

Bachelors or Master's degree in Engineering or Life Sciences. 

4-6 years’ experience in relevant field. 

2-4 years with Master 

Knowledge, Skills, and Abilities 

Proven knowledge in regulatory requirements, process control, manufacturing systems, and biopharmaceutical manufacturing principles and techniques.

Strong management, communication, interpersonal, organizational, project management skills, and ability to work within multi-disciplinary teams.

Technical proficiency, leadership, creativity, strategic thinking, and expertise in biopharmaceutical manufacturing processes and technologies, with strong interaction skills with collaborators and vendors.

Work Environment/Physical Demands/Safety Considerations

 Work in office and, to a lesser extent, laboratory environment. 

May be on feet for 4 to 5 hours a day. 

Lifting up to 25lbs may be required 

May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment. 

May work with hazardous materials and chemicals 

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of California is $69,300-128,700.  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, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.