Solutions Architect

Title21 Health Solutions, a leading provider to the Health and Life Science domain, is seeking a Solutions Architect at its Pleasanton, CA location to facilitate the delivery of world-class automation solutions. The Solutions Architect is responsible for providing architectural leadership for the deployment of Title21 Cellular Therapy solutions into the customer environment. This position requires the ability to establish comprehensive understanding of the Title21 Cellular Therapy (CT) Platform, Quality Management systems and their related technology stack, as well as mastering the requirements of the cellular therapy manufacturing and clinical domains.

 

Responsibilities 

  • Deliver complete customer delight!

  • Providing architectural and technical leadership to the Title21\Customer core project teams in the performance of software deployments in the CT and other biologic and drug manufacturing domains.

  • Formulate, synthesize and develop effective solutions in the course of deployments into the customer environments.

  • Reconciling varied customer requirements to map into the Title21 Cellular Therapy Platform.

  • Ensuring the proposed and implemented solutions meet Title21, customer and regulatory requirements, as well as project scope, timing and budgets.

  • Support the sales and marketing team with product demonstrations, RFP responses, and similar pre-sales support activities.

  • Facilitate communications between the Product Implementation Team and Title21 Development in assessing and characterizing customer product enhancement requests and issues.

  • Assisting and guiding team members in their understanding and acceptance of your proposed solution(s).

  • Advise Title21 senior management of identified opportunities, strengths, weaknesses, and threats in the Title21 strategic domains.


Minimum Job Requirement

Candidates MUST have 2-4 years successful experience leading major software deployments into a Life Sciences or Healthcare organization from the vendor side (not client side).


Required Skills

  • Demonstrable and successful experience (2-5 years) as a Solutions Architect, or in a similar capacity, in the role of vendor deploying a solution into the customer environment, or alternatively, working as a member of an institutions software deployment team, in the course of implementing a highly configurable software system in the clinical setting or within a biologic/drug manufacturing facility. Relevant systems experience in the clinical setting includes EPIC (with EPIC certification), Cerner, or in the manufacturing setting Emerson, Werum, etc.

  • Ability to communicate, articulate and effectively present organizational strategies, technological roadmaps, product attributes, differentiators and benefits to C-Suite audiences.

  • Strong technical skills as well as strong leadership traits and capabilities.

  • Strong familiarity with applicable regulations and standards including relevant FDA, AABB, FACT, ISCT and related requirements.

  • Experience in leading cross-functional teams in high-profile projects (with external customer team members), resolving project road-blocks, and achieving project objectives.

  • Strong familiarity using common project support toolsets such as project management systems, SharePoint, etc.

  • Excellent verbal and written communication skills.

  • Domain expertise and strong familiarity with the requirements and workflows in one or more of the following areas:

    • BMT Programs, including Clinical, Laboratory, and post infusion.

    • Cell and Gene Therapy Labs, including experience in protocol development and translational efforts in the support of Phase I and Phase II trials.

    • Biologic or Drug manufacturing, especially with regard to processes development and support systems (e.g. Master Batch Record development, Resource Planning, Inventory, etc.).

    • Quality Management support systems (Document Control, Error Management, Learning Management, etc.) in clinical or manufacturing environments.

 

Highly Desirable Skills and Experience

  • Familiarity and/or experience with external software system and instrument integration and operability using HL7 and similar protocols.

  • Familiarity with Windows based technology stacks including authentication, remote access/VPNs, TCP/IP, security protocols, etc.

  • Familiarity with FormsNet3 and CIBMTR.

  • Familiarity with Product Validation concepts and workflows.

  • Familiarity and experience using and desktop development systems such as MS Visual Studio, MS Access, etc.

  • Expertise with various aspects of MS SQL Server or similar SQL systems (e.g. Oracle, MySQL, etc.).



Personal Traits

  • Ability to work independently and self-starting.

  • Enjoy working on a team with enthusiastic, talented professionals; being a team player and enjoying a collaborative environment is essential.

  • Ability to be agile in a high growth, fast-paced environment.

  • Willingness to learn, grow and take on more responsibilities in new areas.

  • Self-starter, reliable, conscientious, hard-working, customer-focused team member.

 

Other

Viable candidates will be able to demonstrate a progression of increasing responsibilities in supporting software implementations in various roles such as Med Techs, Business Analyst, Clinical Implementation Specialist, Project Managers and similar capacities.

 

Educational Requirements

Minimum 4-year degree in Computer Science, Technology, Medical or similar degree. Master’s degree in similar is desirable.

 

Position Type

Full-Time Employment; Non-Exempt

 

Location

This position is located in Pleasanton, California.

 

Compensation

Title21 Health Solutions provides a highly competitive compensation and benefits package including:

  • Medical Plan
  • Dental/Vision plan
  • 401(k) with company match and 100% Immediate Vesting
  • Paid Holiday/Vacation/Personal days
  • Life Insurance Plan
  • Disability Insurance

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