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 Technical BioPharma Manufacturing Automation Engineer IV SFD-TC plays a vital role in our Manufacturing and Automation team. The engineer will establish automation specifications, drawings, and SOPs, and will support operations and projects as the technical lead. The role may independently scope and manage small to medium automation projects and will collaborate with manufacturing, validation, quality, engineering, and facilities personnel to enable successful clinical to commercial manufacturing, support tech transfer, and to continue to drive improvement projects as the facility grows. The automation engineer may represent Astellas Gene Therapies as the technical SME for owned systems in audits and investigations.

Responsibilities:

• Technical SME and system administrator for assigned systems which will include GMP SCADA system, manufacturing systems (control systems for bioreactors, chromatography, etc.), PI Historian, and/or Environmental Monitoring System.

• 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 interdisciplinary groups (Manufacturing, Quality Assurance, Quality Control, Process Development, Facilities, etc.).

• As assigned, this position may be required to work during non-traditional work hours to support critical business operation.

Quantitative Dimensions:

The Technical BioPharma Manufacturing Automation Engineer IV SFD-TC will be the technical lead that will be responsible for establishing and supporting automation systems. The role will ensure successful GMP manufacturing, tech transfer, and be accountable for owned systems during any audits and investigations.

Organizational Context:

The Technical BioPharma Manufacturing Automation Engineer IV SFD-TC will typically report to the Lead BioPharma Manufacturing Automation Engineering SFD-TC. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Required Qualifications:

• BS in Engineering or related degree and 5+ years of direct automation engineering experience or MS in Engineering or related degree and 3+ year of direct experience in automation engineering experience.

• Comparable combinations of education and/or experience may be considered.

• Working knowledge of GAMP, cGMP, and 21 CFR Part 11.

• Strong communicator with ability to work independently and as part of a team.

• Strong and effective problem-solving skills.

• Support and demonstrate quality standards to ensure data of highest quality.

• Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Preferred Qualifications:

• At least 5 years of experience in a biotech GMP manufacturing environment.

• Experience with OSIsoft/AVEVA PI systems, Rockwell PLCs, Siemens PLCs.

• Experience with Ignition SCADA systems.

• Experience with plant utilities, clean utilities, cell culture, chromatography, and support processes.

• Experience with Single Use Manufacturing.

• Experience with system integration.

• Computer System Validation Expertise.

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

• This position may be required to occasionally work during non-traditional work hours and participate in an on-call rotation for support calls.

• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).

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 Sanford TC

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

EOE including Disability/Protected Veterans