Automation Engineer
Audentes Therapeutics - South San Francisco, CA
posted 6 months ago
About the position
The Automation Engineer at Astellas Pharma Inc. plays a crucial role in the development and delivery of innovative therapies for patients. This position is centered around providing technical expertise and support for programmable and robotic lab equipment, environmental monitoring systems, and AAV production skids within the research and technical operations lab and production environments. The Automation Engineer will serve as a Subject Matter Expert (SME) and system administrator for various GxP systems, including control systems for bioreactors and chromatography, as well as Environmental Monitoring and Building Management Systems. In this role, the engineer will support the integration of various technologies such as PLC, SCADA, DCS, and MODBUS, and will be responsible for the migration and upgrade of PI suite components. The engineer will also oversee the end-to-end implementation of enterprise and site-specific PI systems, providing technical support and services at a high level. Responsibilities include authoring and maintaining various specifications and standard operating procedures (SOPs) for owned systems, managing change controls, deviations, and corrective actions related to automation, and troubleshooting real-time processing and control issues. The Automation Engineer will collaborate closely with multiple teams within Astellas, including Quality Assurance, Quality Control, and IT, to ensure the smooth operation of automation systems. This position may require working during non-traditional hours to support critical business operations and involves designing custom dashboards and reports, as well as integrating business intelligence tools. The ideal candidate will have a strong background in automation within the pharmaceutical or biotech industry, with a focus on strategic thinking and customer service to drive ongoing operations and achieve set objectives.
Responsibilities
- Serve as a technical SME and system administrator for assigned GxP systems, including control systems for bioreactors and chromatography.
- Support integration of technologies such as PLC, SCADA, DCS, and MODBUS.
- Manage migrations and upgrades of PI suite components.
- Implement and provide technical support for enterprise and site-specific PI systems.
- Author and maintain Functional Specifications, Design Specifications, Configuration Specifications, and SOPs for owned systems.
- Manage Change Controls, Deviations, and CAPAs for automation-related changes.
- Troubleshoot real-time processing and controls issues and assess impact of deviations.
- Contribute to the development and maturation of the facility, setting standards and direction for the site.
- Author, review, and execute automation test protocols.
- Collaborate with various Astellas teams including Quality Assurance, Quality Control, and IT.
Requirements
- BS or MS in Engineering or equivalent degree.
- Working knowledge of GAMP, GxP, and 21 CFR Part 11.
- Experience with AWS architecture, storage, computational and data processing technologies.
- Minimum of 10 years of automation experience within the pharmaceutical or biotech industry.
- Excellent communication and interpersonal skills.
- Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment.
- Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
- Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
- Proven track record of excellent judgment, problem resolution, teamwork, budgeting and/or Excel skills, decision-making skills, and the ability to work under pressure.
- Ability to apply strategic thinking and customer mindset to ongoing operations.
Nice-to-haves
- Experience working in a Cell & Gene Therapy research environment.
- At least 5 years of experience in a biotech GxP environment.
- Experience with Scitara, Benchling ELN system, OSIsoft PI systems, Rockwell PLCs, Siemens PLCs, GeneData suite.
- Experience with Building Management Systems and Environmental Monitoring Systems.
- Experience with laboratory equipment such as Bioreactors, Genetic sequencing and data collection devices.
- Experience with Cytiva Unicorn and Sartorius BioBrain and MFCS/win control systems.
- Experience with system integration.
- Computer System Validation Expertise.
Benefits
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
