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
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
The Role
As part of the Astellas Gene Therapies Research Engineering & Facilities team, the Principal Systems 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 Principal Systems Engineer must be a team player that understands the importance of collaboration and can also take direction and drive the resolution of issues to completion with minimal supervision. Some travel may be required.
Primary Responsibilities
Lead and support a governance forum of stakeholders focused on delivering strategy, awareness, and support for the IT/OT systems and assets and aligning with IS organization impacting corporate systems roadmaps.
Research technologies, architect and propose solutions, develop roadmaps, and draft detailed design specifications to meet the needs of the stakeholder group requirements.
Responsible for design and configuration of systems, applications, and activities related to systems deployment.
Perform system administration on multiple core IT platforms as trained/required (Domain, Network, etc.)
Perform routine preventative maintenance (operator workstations, label printers, and wireless devices) and change control (patches, updates, upgrades).
Provide varying levels of technical assistance to operations teams as a component of managing IT systems deployment.
Investigate and troubleshoot technical problems of increasing complexity utilizing system documentation and support contracts to solve complex problems.
Address system outages and other issues impacting systems and processes, working with operations teams to identify, prioritize, and resolve issues.
Perform deviation investigations and deliver corrective and preventive actions.
Provide documentation for the preparation, deployment, procedures, and design of IT systems.
Verify acceptable performance and accessibility of newly deployed IT solutions.
Work with third party vendors/partners to design, deploy, and support IT solutions.
Support the Information Systems team in the design, documentation, and implementation of infrastructure technology related to both lab and manufacturing environments.
Assist Information Systems with the planning and execution of computerized systems or network changes and/or process improvements.
Monitor and troubleshoot daily system backups and develop, test and maintain disaster recovery procedures.
Work schedule includes ‘out of normal’ work hours for IT support, maintenance, or other activities as required.
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' supporting IT or IS in a biotechnology or pharmaceutical lab or manufacturing environment.
Experience provisioning new IT solutions in support of business processes.
Experience using multiple tools to collaborate remotely with staff and contractors.
Understanding of network connectivity and troubleshooting related user issues
Demonstrated understanding of IT Support as part of a business function (SLA’s, ITIL practices, etc.)
Strong technical writing and oral communication skills
Successful experience in a mid-size corporate environment, strong collaborator in a team atmosphere, thrives on new challenges, and has a demonstrated history successfully executing technology solutions for business challenges.
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
Preferred Qualifications
Exposure to validated environments, change management, and regulations.
Experience with systems including MFCS/win, UNICORN, OSI PI, Schneider BMS, Vaisala EMS, RF Smart, Benchling, Signals, and PIMS a plus
Experience with computer system validation is a plus
Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals
Experience designing and configuring applications for integrating Information Technology networks with Operation Technology equipment and networks.
Experience supporting users, applications, lab equipment, and instruments in lab and pilot plant environments.
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.
Salary Range : $129,800-$173,000 (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
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Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans