Job Title: STARLIMS Software Engineer  

Department: Information Technology

Location: Remote, United States  

Hours Per Week: 40

Schedule: Monday – Friday, Days

SUMMARY

The Software Engineer - STARLIMS is responsible for performing configuration, customization, and maintenance tasks within the STARLIMS system to support laboratory operations. This role focuses on executing development activities under the guidance of senior team members, ensuring all work complies with established Computer System Validation and Change Management procedures. The Software Engineer will primarily assist in analysis, design, coding, testing, documentation, troubleshooting and fixing application components and connected systems.

RESPONSIBILITIES

• Work collaboratively with business analysts, testers, and client end-users to understand system requirements and implement optimal solutions.
• Develop, configure, and customize established STARLIMS workflows, reports, and dashboards based on documented requirements. Assist in analysis, coding, testing and validation efforts for new features, bug fixes, and system upgrades/patches.
• Perform routine maintenance and operational support for STARLIMS and related integration incidents (Break/Fix), escalating complex issues to senior engineers.
• Execute pre-defined code changes and update custom scripts under supervision. Support STARLIMS upgrades/patching to ensure functional compliance.
• Manage the utilization / management of STARLIMS services / API, including the development of custom scripts.
• Collaborate with end-users and senior team members to clarify requirements and test solutions.
• Maintain and update technical documentation (configuration guides, test scripts) using tools like JIRA.
• Assist in data migration and data cleanup activities during system updates.
• Follow and adhere to defined application development standards, best practices, and IT Security principles.
• Support the setup and testing of basic interfaces using standards like HL7, JSON, APIs, others with 3rd party systems and Instruments / instrument middleware
• Develop and maintain sample/workflow management modules, reporting and dashboard components, Stability management, inventory, and instrument management modules
• Customize business rules, forms, calculations, and user interfaces.
• Troubleshoot system issues and provide tier-2/3 technical support.
• Perform upgrades, patches, hotfix deployments, and version migrations.
• Improve system performance, stability, and security.
• Create / assist in the development and maintain technical design documents, SOPs, configuration specs, and release notes.
• Support validation activities, IQ/OQ/PQ documentation, test scripts and execution, change control processes
• Ensure compliance with FDA 21 CFR Part 11, GxP, MHRA, and other applicable regulations.
• Code development using best-practice IT security principles.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in computer science, information systems, or related field or equivalent relevant experience.
• 4+ years of experience in STARLIMS development, including configuration, customization, and integration

PREFERRED QUALIFICATIONS

• Excellent programming and problem-solving skills; capable of architecting and troubleshooting highly complex STARLIMS and other software solutions using: HTML, JavaScript, SQL, scripting languages, stored procedures (SQL Server and Oracle) etc.
• Deep technical understanding of STARLIMS system coding and architecture, performance tuning, and database optimization.
• Ability to translate business needs in implemented or new customized workflows in STARLIMS.
• Proven track record of CSV and GAMP compliant software development projects in a regulated life sciences environment.
• Familiarity with industry regulations (GMP, GLP, CLIA, ISO, GxP, 21 CFR Part 11, MHRA) through secure and compliant solutions.
• Ability to participate and contribute to technical discussions, collaborate effectively with business stakeholders, and drive technical consensus.
• Strong understanding of Agile/Scrum methodologies and DevOps practices for LIMS development.
• Experience in pharmaceutical, biotech, public health, or forensic laboratory environments.
• Knowledge of GxP/GLP guidelines, audit trails, and regulated system validation.
• Familiarity with automation/instrument integration standards (ASTM, HL7, XML, REST APIs).
• Experience with STARLIMS Mobile, Advanced Analytics, or SDMS modules.
• Understanding of laboratory workflows and LIMS concepts / Experience working in a laboratory is highly desired.
• Strong proficiency in:
• JavaScript, HTML5, CSS
• SQL Server (queries, stored procedures)
• .NET or related backend languages (depending on environment)

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.