Engineer IV, Information Systems

Company: BioSpace, Inc.
Location: Durham
Posted on: May 27, 2023

Job Description:

Job Details

The Systems Engineer provides IT support and services for on premise computer systems. These computers and systems, used for R&D and Production activities, enable our lab, manufacturing and business teams to carry out critical experiments, produce the products we manufacture, and run our business. They allow our teams to be more efficient, and enable our digital strategy.

The Systems Engineer requires interaction with a variety of stakeholders including our customers on the business, manufacturing, Automation, and Quality teams as well as our colleagues on the infrastructure, Security Operations, and Desktop support teams. The systems engineer will ensure our systems comply with all applicable regulations, code, and procedures and will provide leadership in the implementation of systems at our Resilience site.

The Systems Engineer will work across technical, manufacturing and scientific domains, help to design and implement on premise and cloud-based data and system architectures, as well as deliver initiatives around raw laboratory instrument data management practices and governance. They will work closely with their peers across our Digitally Enabled sites to ensure maintain a consistent alignment and approach for operations and support of our biomanufacturing systems.

This scope of responsibility includes systems implementation, computer systems validation, project management, close-to-the-instrument support, and coordination with bioinformatics teams. The successful candidate will implement solutions for cloud-native laboratory systems where possible, ensuring that data solutions meet the needs of our researchers and consumers of laboratory data all while maintaining the highest level of information security, system integration, and data availability.

Responsibilities

• Maintaining, configuring, and ensuring reliable operation of our computer systems, virtual environment, and integration/automation processes.
• Design and implement procedures for the support and management of computers, computerized systems, and devices
• Deliver GxP validation execution for enterprise systems deployments
• Implement systems policies, standards, and procedures aligned with enterprise standards/templates.
• Ensure the secure connection of our systems whether locally or to the cloud
• Provide direct support to our customers and act as an escalation point for enterprise systems events
• Monitor system configuration and use account privileges to ensure data integrity
• Partner with vendors and security operations to assess system patches and updates prior to implementation to ensure they do not conflict with computerized systems
• Provide day to day end user support for business and lab systems
• Represent the end user on cross-functional IT infrastructure projects to ensure electronic systems remain compliant
• Support continuous improvement initiatives and CAPAs related to business and automation systems
• Provides customer support and training, troubleshoot problems, and perform system maintenance, as needed
• Establishing integrations between various IT systems.
• Troubleshooting hardware and software errors by running diagnostics, documenting problems and resolutions, prioritizing problems, and assessing the impact of issues.
• Assisting service desk with support efforts, making sure all desktop applications, workstations, and related equipment problems are resolved in a timely manner with limited disruptions.
• Providing documentation and technical specifications for planning and implementing new IT systems or infrastructure.
• Analyzing business operations and the business's computer systems to improve efficiency.
• Maintaining up-to-date knowledge of the latest software developments. Qualifications
  • 10+ years relevant work experience in biotech/pharma administering ERP, SCADA, Manufacturing, and business system software
  • 8+ years experience with business system software
  • 4+ years cloud-based systems implementation experience
  • Experience with evaluating, implementing, and managing scientific data management platforms
  • Ability to adapt to increasing scope and complexity of work brought on by growth/change and helps others manage through change
  • Knowledge of 21 CFR Part 11, Annex 11 Regulations and GMPs preferred Preferred Experience
    • Bachelor's degree with equivalent experience, in IT or life science-related field
      
      Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $110,000.00 - $140,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Keywords: BioSpace, Inc., Durham , Engineer IV, Information Systems, IT / Software / Systems , Durham, North Carolina