TD&O Sr Lab Systems Engineer

Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Posted
November 24 2021
Ref
789721000
Organization Type
Biotech
TheSr Lab Systems Engineerwill assist in the development and execution of Spark’s TD&O Lab Digital Systems Program. This role will lead the deployment and establish support models for TD&O lab digital systems working directly with end users, cross functional teams including IT, and software providers. This individual will be the hands-on expert for lab digital systems deployed to the TD&O organization. They will be responsible for ensuring SDLC processes and Good Documentation Practices are followed in the delivery of digital system capabilities.

Systems in the scope of this role include:

  • Electronic Lab Notebooks (ELN)
  • Laboratory Information Management Systems (LIMS)
  • Scientific Data Management Systems (SDMS)
  • Lab Execution Systems (LES)
  • Other laboratory instrument management systems
Responsibilities

Job Function and Description

Provide project and technical leadership to the TD&O Lab Digital Systems Program and ensure it will contribute to the company achieving its long-term strategic goals. Evaluate conceptual aspects of technical designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.

Ensure plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Meet scheduled milestones to ensure project/program objectives are met in a timely manner. Use agile development principles, in accordance with Corporate IT standards, where applicable.

Manage and build strong relationships with software vendors and SaaS providers and stay up to date on all system information including features/updates/patches/roadmaps.

Serve as the technical SME on lab systems and provide end users support as needed.

Collaborate with Corporate IT to ensure digital systems leveraged by TD&O are ideated, evaluated & selected, approved, constructed, delivered, and supported in accordance with Spark principles, policies, and standards.

Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices.

Education and Experience Requirements

  • Bachelor’s degree with 8+ years of experience or
  • Master’s Degree/PhD with 6+ years of experience
  • Preferably in the Life Sciences/Engineering/Computer Sciences or related field.
  • Minimum 6 years of experience in the Biotechnology or Pharmaceutical industry working with and supporting Lab applications.
  • Hands-on development experience with lab system customizations/configurations and data models.
  • Experience with SaaS deployments with a focus on configuration, API development and lab system integrations.
  • Experience with the SDLC and Good Documentation Practices.
  • Proven track record organizing and delivering applications from concept to go-live in a lab environment.
  • Demonstrated technical project management experience to develop project goals, budgets, deliverables, and timelines.
Key Skills, Abilities, and Competencies

  • Intricate knowledge of laboratory systems including but not limited to ELN (Benchling preferred), LIMS (LabWare preferred), LES, SDMS (NuGenesis preferred)
  • Familiarity with lab master data management
  • Deep understanding of lab data workflows and optimization techniques
  • Ability to effectively communicate to scientific end users and provide training on lab software packages
  • Regulatory Inspections, GoodManufacturing Practice (GMP), Change Control, Validation
Complexity and Problem Solving

  • Lab system troubleshooting - Incident investigation and root cause analysis and when and how to escalate
Internal and External Contacts

  • Accountable to TD&O
  • Internal Contacts – QC, QA, Manufacturing, Manufacturing Science & Technology, Data Science, Environmental Health & Safety, Technical Development, Analytical, Automation, Corporate IT, Finance, and R&D
  • External Contacts – Vendor ecosystem
Other Job Requirements

  • 0 - 15% domestic travel

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

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