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The Position
As a Manufacturing Engineer, you will provide engineering capabilities and expertise in either upstream or downstream processes. Your primary focus will include designing, implementing, and starting up new and existing stainless-steel facilities, as well as new single-use facilities, with respect to process and clean utility systems. Key responsibilities encompass managing procurement activities, overseeing fabrication, conducting factory acceptance testing, coordinating site installations, performing site acceptance testing, managing start-up procedures, ensuring validation, monitoring processes, troubleshooting, and facilitating technology transfer. Additional duties involve executing commissioning and process validation protocols. Proficiency and experience working under Good Manufacturing Practices (GMPs) and meeting validation requirements are essential for success in this role. The Opportunity
Review design drawings and provide recommendations, which may include process flow diagrams (PFDs) incorporating mass balances and piping and instrumentation diagrams (P&IDs), detailing all line sizing, instrumentation, and control philosophies. Collaborate with other functions to address process and equipment-related issues. Generate controlled documents to support start-up, operation, validation, and maintenance of equipment and systems. Participate in root cause analysis and troubleshooting activities. Oversee external consulting engineers and provide process overviews, reviewing the drawings and documents produced by these groups. Conduct factory inspections of vendor-supplied equipment to ensure construction and performance meet specifications. Provide critical input for the validation of process equipment and associated utilities, directing manufacturing and operations staff in the execution of validation protocols. Propose new project ideas in alignment with strategic planning. Ensure that all employees with Warehouse access can pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). Integrate environmental health, safety, and security into business processes, systems, and programs, while reporting safety and environmental incidents, including injuries, illnesses, and safety suggestions within one's functional area. Foster a positive safety culture where no one gets hurt.
Who you are
Bachelor's degree in Engineering (Chemical preferred) and 4 years applicable equipment, clean utility and process system experience, or Master's degree in Engineering (Chemical preferred). Minimum 2 year applicable instrument and control system experience. Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience.
Job Requirements
cGMP and Validation Experience: Knowledge of cGMP guidelines, generation of controlled documents, equipment start-up and validation experience, and compliance with GMP requirements. Technical Proficiency: Ability to generate engineering drawings and specifications, experience with AutoCAD, and working knowledge of computer-based programs and Windows applications for control systems. Manufacturing and Design Expertise: Experience in manufacturing, design, or construction, with understanding of clean room/classified area design and biopharmaceutical manufacturing processes. Process and Systems Knowledge: Knowledge of biopharmaceutical process operation, process equipment, supporting utility systems, and process controls for troubleshooting and future designs. Creative Problem Solving: Proven ability to use creativity and innovation to address complex problems using a wide variety of technical skills. Strong Communication and Organizational Skills: Strong written and verbal communication skills, along with good organization, effective time management, and the ability to work autonomously on assignments and projects.
Work Environment/Physical Demands/Safety Considerations
Work in an open office environment. 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 make up or jewelry can be worn when working in the clean room environment. May work with hazardous materials and chemicals.
Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $80,500 - $149,500 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.
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Genentech
Apr 23, 2025