Senior Engineer, Lab Systems and Applications

Senior Engineer, Lab Systems and Applications

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

As part of the Data Systems & Controls team, the Senior Labs Systems and Application Engineer will deliver IT support for our pilot plant and research laboratory systems, working onsite at our South San Francisco, CA location. This role requires advanced technical skills and a strong focus on customer service and systems ownership. The Senior Labs Systems and Application Engineer must be a team player that understands the importance of collaboration and can drive projects and the resolution of issues to completion with minimal supervision and effective utilization of vendor and contract resources. Some travel may be required.

Responsibilities

Leads projects to deliver or enhance systems and applications through researching technologies, developing solutions or roadmaps, and drafting design and configurations to meet the needs of stakeholder group requirements

Responsible for systems ownership, administration, and deployment including routine preventative maintenance, change control, procedure development, and technical assistance to operations

Investigates and troubleshoots technical problems of increasing complexity, utilizing system documentation, and addresses system outages / issues impacting operations by identifying, prioritizing, and resolving issues

Monitors and verifies acceptable performance and accessibility of newly deployed IT solutions and performs investigations and deliver corrective actions, as required

Supports the Digital Analytical Technologies team in the implementation of network and infrastructure changes impacting the lab and production systems and applications

Ensure compliance with lab instrument backup & archiving disaster recovery requirements.

Work schedule includes ‘out of normal’ work hours for IT support, maintenance, or other activities as required

Organizational Context :

This position is a technical and team leadership position reporting to the Associate Director, Data Systems & Controls within the Astellas Gene Therapies Research & Technical Operations Division.

Required Qualifications

BS / BA degree in engineering, information systems or equivalent with a combination of education / work experience

10+ years of relevant IT or IS environments and solutions, in an administrator or technical expert role

6+ years of supporting IT or IS in a biotechnology or pharmaceutical lab or manufacturing environment

Experience provisioning new IT solutions in support of business processes

Experience with computer system validation

Experience using multiple tools to collaborate remotely with staff and contractors

Demonstrated understanding of IT Support as part of a business function (SLA’s, ITIL practices, etc.)

Strong technical writing and oral communication skills

Models our Values : Be Bold : Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Supporting integration of various technologies such as PLC, SCADA, DCS, OPC DA / UA, RDBMS, MODBUS.

Technical SME and system administrator for assigned systems, which will include GxP systems (control systems for bioreactors, chromatography, etc.),

Support and troubleshoot LIMS and ELN automated data workflows.

Provide varying software and hardware levels of technical assistance to operations teams as a component of managing systems deployment.

Map system processes and maintain system documentation and system inventory.

Preferred Qualifications

Experience with validated environments, change management, and regulations

Experience with designing information interfaces, data conversions, and network and infrastructure fundamentals.

Experience with designing information interfaces, data conversions, and network and infrastructure fundamentals

Experience designing and configuring applications that integrate Information Technology networks with Operation Technology equipment

Experience supporting users, applications, lab equipment, and instruments in lab and pilot plant environments

Experience with Tetrascience, Scitara, Benchling or Signals A-Note ELN systems, Labware LIMS, OSIsoft PI systems, MFCS / win, UNICORN, Rockwell PLCs, Siemens PLCs, GeneData suite, Blue Mountain RAM.

Working Conditions :

• This position will be hybrid, requiring onsite work at least three days per week or as needed to fulfill duties, with travel requirements of less than 10%.

Salary Range : $103,600 - $148,000 (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.

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Category Facilities, Engineering and Logistics

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

EOE including Disability / Protected Veterans