Engineer II/Sr Engineer, Automation

Company: GENENTECH
Location: Oceanside
Posted on: January 12, 2021

Job Description:

The Position Location: Oceanside Essential Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement. Produce and review design drawings and specification documents (URS, FS, DS, etc.). Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services. Generate, execute, and review Installation, Operational, Performance Qualification protocols. Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.) Initiate, execute, and track progress of change records. Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget. Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met. Lead the start-up and troubleshooting of automation and critical process utility systems. Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. Adhere to site standard operating procedures (SOPs) and work instructions (WIs) for daily and project deliverables and drive improvements to business processes. Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). Attendance and participation in department and staff meetings. Maintain training qualifications. Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. Automation lead for equipment/software FAT, field testing and commissioning Interact with vendors ensure systems meet site requirements Provide scope, qualification, resource, and budget estimates for automation impacting projects. Manage contractor staff, track project deliverables, and provide status updates to project team. Generate, review, and maintain Master Plans and Project Plans with automation scope. Select external contractors with appropriate skill sets. Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices. Provide input into network/global business processes and procedures (e.g. GSPs). 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. Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting. Education and Experience Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7years experience. Minimum of 8 years applicable automation and/or instrument and control system experience. 5 year in the pharmaceutical/biotech industry/GMP experience. Knowledge, Skills and Abilities Experience with Biopharmaceutical manufacturing, design or/and construction. Knowledge of process, utility and building control systems. Knowledge of GMP guidelines, experience in generation of controlled documents. Qualification experience related to control and computer systems. Ability to generate engineering drawings and specifications. Practical knowledge of ISA standards and practices for instrumentation. Practical knowledge of PID control theories and techniques. Practical knowledge of programmable logic controllers, and associated programming languages (RSLogix Preferred). Practical knowledge of distributed control systems, and associated programming languages (DeltaV and Siemens Insight Apogee Preferred). Practical knowledge of Manufacturing Execution System (Syncade Preferred). Knowledge of computer aided manufacturing automation. Demonstrate good organizational and time utilization skills. Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels. Demonstrate good written and verbal communication skills. Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility. Demonstrate strong working knowledge of PC based programs and web based systems. Ability to work independently with no direct supervision. #LI-PTJT1 #PTcareers Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page . Job Facts JOB FUNCTION Production Engineering COMPANY/DIVISION Pharmaceuticals SCHEDULE Full time JOB TYPE Regular

Keywords: GENENTECH, Oceanside , Engineer II/Sr Engineer, Automation, Other , Oceanside, California