Lab Systems R&D Specialist

Lab Systems R&D Specialist (Contract) Hybrid CA

Global Biotech organization seeks LIMS & SDMS Lab Systems Specialist for a year+ contract hybrid opportunity with 3 days onsite local to San Francisco, CA.

Ideal candidate will have a background working within a laboratory, and 4+ years direct experience implementing and validating software within a regulated environment.

2+ years utilizing LIMS and SDMS, with ideal expertise in Watson LIMS and NuGenesis SDMS. Individual must also have extensive instrumentation integration, and strong Business Analysis including requirements gathering, process mapping (specific to SDMS, Lab instrumentation and processes) and strong documentation expertise (SOPS, Data / Process Flows, SDLC deliverables URS, FRS, Configuration Specs, Test Scripts, etc.

The Lab Systems Specialist will work in R&D to implement instrumentation systems and software requirements to meet business needs.

Data management and writing test scripts are also required. Opportunity affords ideal candidate a long-term contract with potential extensions and exposure to a global organization and project.

Responsibilities

• Performing instrumentation and workstation interfacing LIMS (Watson), SDMS (NuGenesis), and Instrumentation (Waters).
• Performing testing while ensuring system meets business needs; resolving defects.
• Analyzing, developing, and documenting lab data workflows and process mapping.
• Collaborating with cross functional stakeholders to perform Proof of Concept testing.
• Developing, reviewing, and obtaining approval of full SDLC documentation.
• Regular utilization and optimization of LIMS and SDLC.
• Partnering with laboratory users and business experts to ensure software requirements are met and utilized.
• Implementing business configurations and administering systems as needed.
• Developing test cases for systems and software to include both Watson LIMS and NuGenesis SDMS.
• Authoring and editing SOPs, work instructions, training materials, Data / Process Flows, SDLC deliverables URS, FRS, Configuration Specs, Test Scripts, and more.
• Working directly with vendors on SDMS, LIMS and instrument configurations.
• Providing post go-live support for a variety of users and systems as needed; while also rolling out solutions and training on system functionality accordingly.

Requirements

• Ability to work onsite within a hybrid role, 3-days per week just north of the Bay area.
• Prior LIMS expertise ideally as business analyst, with a preference for Watson LIMS.
• Prior SDMS expertise, with a preference for NuGenesis.
• Prior instrumentation integration expertise, with a preference for Waters.
• Prior experience working with laboratory analysts to perform end-to-end business process testing between instrumentation, SDMS, and Downstream systems.
• A history of working within the laboratory having experience initiating and management Change Control and Deviation requests.
• Expertise in data integrity and management to include data workflows and processes within regulated R&D environment.
• Be located in San Francisco Bay area, to work onsite within a hybrid role.

Benefits

• Afford W2 or 1099 Candidate ability to work within a long-term contract for a global organization.
• For W2 consultants, the option for health, vision, and dental benefits.
• A hybrid opportunity with 2-day work-from-home schedule
• Exposure to cutting edge systems to include Waters Instrumentation, SDMS NuGenesis, and Watson LIMS.
16 days ago