Automation Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role

The primary purpose of a Senior Automation Engineer role is to be an advisor and technical expert for programmable and robotic lab equipment, environmental monitoring and building management systems, and AAV production skids and historian at our research and technical operations lab and production environments.

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 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.

Required Qualifications

• 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

Work Conditions

• This position will be hybrid, with onsite work required at least 3 days per week and will require less than 10% travel.

Salary Range : $132,000 - $176,000 (NOTE: Final salary could be more or less, based on experience)

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Category GT - Engineering & Facilities

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans