· Job facts
As an Automation Engineer II, you are responsible in providing support for bio-pharmaceutical manufacturing projects and operations for the Downstream Automation group with a focus on Drug Product. Area of focus will primarily be supporting manufacturingcomputer/automation/processcontrol systems to ensure reliable operation of Drug Product systems, including Commercial and Clinical fill lines and associated control systems used in and supporting bulk processing, the filling of recombinant proteins, packaging, and inspection. Candidate must be a self-starter, who can independently drive projects and day-to-day work tasks to completion according to a defined budget and schedule. The candidate must be able to work well with others in an informal results-oriented environment.
· Manufacturing technical support. Provide 24x7 on-call for manufacturingcomputer/automation/processcontrol systems.
· Monitoring and analysis of manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
· Developing and implementing technologies which enhance manufacturing operations
· Support implementation of projects of various magnitude to maximize success rates, reduce discrepancies, increasecapacity/productivity,increase levels of safety and/or compliance.
· Design and execution of large and/or strategic projects in line with overall department and plant strategies, including: project approach and resource needs, options analysis, execution plan, engineering document development, and system ownership through the project delivery life cycle of planning, design, implementation, installation, commission and qualification.
· Contribute towards infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes to increase efficiency and effectiveness of the Automation group. Candidate should have a mindset of sharing insights and improvements, and participating in/lead design reviews.
· Ensure that systems achieve a high level of performance, reliability and regulatory compliance.
· Author and maintain detailed design documents, system architecture diagrams and standard operating procedures.
· Provide technical leadership, guidance and mentoring to staff including projects, continuous improvements andinspection/regulatoryreadiness initiatives.
· Assess and manage risks associated with system operation and use, and design, and implement improvements.
· Support site audits and inspections, and implement corrections as needed.
· This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents. As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
· B.S or M.S. in Chemical, Electrical or Mechanical Engineering or equivalent degree
· 5+ years of relevant work experience/training.
· Working experience supporting multiple controller platforms (such as Allen-Bradley PLC 5 & ControlLogix, Siemens, etc.) and interfaces (GE iFix, RSView, etc.), as well as historian and SQL/database experience.
· Experience at reviewing instrumentation and electrical wiring diagrams, communication networks, installation and troubleshooting.
· Theoretical and applied knowledge of process instrumentation, classical process control, continuous process control, Electrical areas and S88 Batch programming, validation and GMP regulations applicable to automated systems (including ISPE GAMP guidelines), ISA standards and P&ID nomenclature.
· Experience working in a cGMP environment
· Requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
· The successful candidate must have strong initiative and integrity as well as strong interpersonal, written and verbal communication skills. They should be able to successfully work independently and within teams, demonstrate strong problem solving skills, partner/customer focus, and the ability to work with complex business systems and processes.
The work environment will require:
· General office work including working on a computer terminal developing engineering documents and software.
· Manufacturing support including working on processing equipment in clean and mechanical spaces within Genentech's South San Francisco manufacturing facility.
· Flexibility for after-hours on call support rotation and support of 24/7 manufacturing operations
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.