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
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 .
Be BOLD (Find a Way)
Care Deeply -- for our patients, each other and our work
#GSD (Get Stuff Done)THE ROLE
The Senior Facilities Automation Engineer plays a vital role in our Manufacturing Sciences and Technologies & Engineering team. The engineer will establish automation specifications, drawings, and SOPs, and will support operations and projects as the technical lead. The role will collaborate with facilities, manufacturing, validation, quality, and engineering personnel to enable successful clinical to commercial manufacturing with a focus on ensuring a reliable, robust Building Management System and Environmental Monitoring System. The engineer will 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.
Essential Job Responsibilities
Technical SME and system administrator for assigned systems which will include a GMP Environmental Monitoring System, a Building Management System, and potentially additional systems depending on site needs.
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 operations 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 (Facilities, Manufacturing, Quality Assurance).
May oversee work for 1-2 automation contractors supporting the BMS or EMS systems as needed.
As assigned, this position may be required to work during non-traditional work hours to support critical business operations
BS in Engineering or related degree and 5+ years of direct building automation engineering and controls experience or MS in Engineering or related degree and 3+ year of direct experience in building automation and controls.
Comparable combinations of education and/or experience may be considered
Experience with plant utilities, clean utilities, and HVAC systems
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
At least 5 years of experience in a biotech GMP manufacturing environment
Experience with Tridium Niagara 4 Building Management System
Experience with Environmental Monitoring Systems
Experience supervising automation contractors
Experience with system integration
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, national holidays, two 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
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans