Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development team. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast paced environment.
Sutro Biopharma is seeking an experienced automation engineer / senior automation engineer that can contribute to the growth of their GMP manufacturing capabilities. The San Carlos manufacturing facility is moving toward increased operations in 2020, and this is an exciting opportunity to be hands on with the startup of equipment and systems that will be used, as well as help define the infrastructure for maintaining these systems and future roadmaps.
The position will be responsible for refining Sutro Biopharma’s automation strategy while authoring and reviewing automation Specifications (URS, FRS, SDS) and SOPs for all automated systems and interactions with manufacturing and utility equipment in the San Carlos GMP facility. The position will involve both facility and system startup / qualification focus to ownership and service focus of automated functionality at San Carlos as the plant moves into Phase 2 operations. The ideal candidate will be highly organized, motivated and an adaptable team player.
- Ability to work with and understand the needs of multiple customers: manufacturing, facilities, project/process/mechanical engineering, quality, validation, etc. Ability to prioritize solutions to meet these needs of the individual functions and company for immediate impact and future growth
- Familiarity and good working knowledge of the basic Biopharmaceutical unit operation equipment: Bioreactors, Chromatography skids, Ultrafiltration skids, Buffer Preparations as well as Spray Drying and CIP operations
- Experience with BMS control systems
- Position will be familiar with all aspects of control system life cycle management (GAMP) in a regulated environment (best if that is FDA regulated) and familiar with all the requirements of making changes, documenting them, and releasing back to production. Familiarity with common quality systems such as change control management
- Represent department in selection of suppliers and vendors for equipment and service with regards to automated equipment serving as liaison to IT, facilities, and manufacturing
- Leads site automation/controls project planning and maintenance
- Troubleshooting support to Manufacturing Operations. On call where necessary
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS
- Minimum of a Bachelor’s degree in an engineering discipline or equivalent; Chemical, Electrical, or Mechanical preferred
- Ideally of 5-15 years of automation and controls experience with a minimum of 3 years working within a GMP pharmaceutical or other highly regulated environment
- Experience in deployment and maintenance of an IT infrastructure to support manufacturing automation systems highly desirable
- Experience in identifying and integrating varied data sources using OPC to improve manufacturing visibility and control
- Significant experience with Allen-Bradley PLC hardware and Rockwell Automation software packages: Studio 5000, PlantPAX Library, FactoryTalk View
- Experience with Administrating OSIsoft PI System, adding and removing tags
- Knowledge of GE Intellution iFix SCADA system
- The candidate for this role must be a logical problem solver and work proactively in response to issues and concerns
- The ideal candidate will have both strong interpersonal skills and technical expertise with the ability to make logical decisions after assessing technical situations
- Perform Data Integrity Risk Assessment (DIRA)
- Ability to run Process related project
- Position may require some travel as part of the role
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.