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IT Business Analyst, QC/PD LIMS

Company: FUJIFILM Diosynth Biotechnologies
Location: Thousand Oaks
Posted on: November 26, 2022

Job Description:

Join FUJIFILM Diosynth Biotechnologies (FDB) in our new facility location - Thousand Oaks, California (FDBC)! The IT Business Analyst, QC/PD LIMS will serve as a liaison between business and technology to assist or gather business requirements needed for the Laboratory Information Management Systems (LIMS). This person will be the subject matter expert and lead for all applications for the Quality Control (QC) and Process Development (PD) department and report to the IT Applications Lead. In addition, this person will lead multiple initiatives for these systems in alignment with the Global FDB IT organization. External US The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.At FDB, passion - what we call Genki - lives inside everything we do. It's within each of our employees, inside our technology, behind our science, fore to our manufacturing process and facilities, in our therapies and biologics, and central to the accomplishments we help make possible for our customers. It's the Genki inside FDB that unites us across sites, energizes our work together forward, and peoples us toward our shared purpose of advancing tomorrow's medicines, together.The IT Business Analyst, QC/PD LIMS role requires an individual with a strong background in LIMS, laboratory / analytical testing equipment and the ability gather and analyze large amounts of complex data and interpret (sometimes incomplete or ambiguous) data sets. Under minimal supervision, the IT Business Analyst is responsible for maintaining the relationship with the business users of the LIMS systems and helping coordinate support with the application vendors and other IT support resources / contractors. The IT Business Analyst (Manager/Senior Manager) will participate in the development of business cases for new QC / PD systems in close collaboration with business stakeholders and both IT and business leadership. In addition, this resource should act as a subject matter expert in the usage, configuration, and support of LIMS systems within the bioCDMO industry. Furthermore, the IT Business Analyst will lead the design, procurement, installation and start-up of new IT systems in accordance with FDB standards and cGMP regulatory requirements.Reports to IT Applications LeadWork Location Thousand Oaks, CA Travel Travel required (Up to 10%)Primary Responsibilities:

  • Serve as the IT Lead for the LIMS systems at FDBC including the following applications: Labware LIMS (v8).
  • Serve as a liaison between business and technology to assist or gather business requirements needed for system modifications, enhancement, and implementations.
  • Gather, analyze and present data, to the FDB Leadership for possible new service offerings and business extensions; support the preparation of investment business cases and make business recommendations.
  • Responsible for interfacing with internal / external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact the bioCDMO business enabling technology options to be identified, evaluated, and compared.
  • Provide project-level analysis producing required documentation (business requirements, functional requirements, validation lifecycle requirements).
  • Deliver functional specifications to include functional hierarchy, workflow, business rules, interface design and definitions, outstanding issues, data analysis, and data mapping.
  • Participate in the development and writing of business cases to support investment across service offerings.
  • Create and maintain business process flow diagrams.
  • Manage new and existing vendor and/or consultant relationships and workloads.
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations and industry codes.
  • Perform other duties as assigned.Physical Demand:
    • Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant or clinical environment.Qualifications:
      • BS/MS preferred in relevant Information Technology or Engineering discipline.
      • 8+ years of relevant Life Sciences experience.
      • 5+ years of experience supporting cGMP Applications, including system implementations.
      • 3+ years of management experience, including coaching junior staff and managing vendors.
      • Excellent verbal and written communication skills required for discussing complex business processes.
      • Technical writing experience.
      • Positive, customer service-oriented skills and behavior.
      • Ability to coordinate, facilitate, and organize resources.
      • Possess the skills and capability to plan ahead and stay on schedule.
      • Strong knowledge of Blue Mountain RAM, Siemens Desigo, ValGenesis/Keat and Avigilon or other similar Engineering and Facilities systems in the life sciences industry.
      • Ability to drive large, complex system implementations.
      • Ability to multi-task and prioritize work assignments with little supervision.
      • Ability to work in a team or independent setting and collaborate with employees from various departments.
      • Desire to work in a fast paced, state of the art, expanding manufacturing facility.
      • Role model for company core values of trust, delighting our customers, Gemba, and Genki.Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FUJIFILM Diosynth Biotechnologies, Thousand Oaks , IT Business Analyst, QC/PD LIMS, Professions , Thousand Oaks, California

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