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Astellas Gene Therapies ยท 2 days ago
Senior Automation Engineer
South San Francisco, CA
Full-time
Onsite
Senior Level
$132K/yr - $176K/yr
10+ years exp
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Responsibilities
Technical SME and system administrator for assigned systems which will include GxP systems (control systems for bioreactors, chromatography, etc.), Environmental Monitoring System, and/or Building Management System.
Supporting integration of various technologies such as PLC, SCADA, DCS, OPC DA/UA, RDBMS, MODBUS
Migrations and upgradations of PI suite components
Enterprise and site-specific PI system end-to-end implementation and technical support/services (L3 and above)
Author and maintain Functional Specifications, Design Specifications, Configuration Specifications, Drawings, and System Administration & Automation SOPs for owned systems.
Own and manage Change Controls, Deviations, and CAPAs for automation-related changes and investigations.
Provide automation expertise to troubleshoot real-time processing and controls issues as well as to assess the impact of deviations.
Contribute to the development and maturation of the facility and help set standards and direction for the site.
Author, review, and execute automation test protocols.
Interact closely with multiple Astellas teams (Quality Assurance, Quality Control, Process Development, IT, Facilities, etc.)
As assigned, this position may be required to work during non-traditional work hours to support critical business operation
Custom dashboard and reports. Designing BI tools integration.
Qualification
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Required
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, some budgeting and/or Excel skills, decision-making skills, and the ability to work under pressure required
Ability to apply strategic thinking and customer mindset to ongoing operations and provide clear, concise guidance and roadmaps to accomplish set objectives
Preferred
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
Company
Astellas Gene Therapies
Astellas Gene Therapies is a biotechnology company that develops new gene therapy treatments and medicines.
201-500 employees
H1B Sponsorship
Astellas Gene Therapies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Growth StageRecent News
2024-04-10
2024-02-20
2023-12-19
Company data provided by crunchbase
