BIOVIA OneLab Foundation Developer

Job Description:

Experience: 6+ years
BIOVIA OneLab Foundation Developer
Job Summary:
We are seeking a skilled BIOVIA OneLab Foundation Developer to join our digital lab transformation team. The ideal candidate will have hands-on experience with BIOVIA OneLab Foundation 2023 SP2, with a strong focus on workflow development, analytical test method configuration, and instrument integration. You will play a key role in designing and deploying digital lab workflows that ensure compliance, improve efficiency, and enable data integrity across regulated laboratory environments.

Key Responsibilities:
• Design, configure, and deploy custom workflows using BIOVIA OneLab Foundation 2023 SP2.
• Build and validate analytical test methods within the OneLab platform for QA/QC and R&D labs.
• Integrate laboratory instruments and equipment (e.g., balances, HPLCs, FTIRs) with OneLab using available drivers, APIs, and instrument connectivity modules.
• Develop reusable templates and digital forms for method execution.
• Translate lab protocols and SOPs into digital procedures aligned with customer-specific compliance and business needs.
• Collaborate with business analysts, lab SMEs, and QA stakeholders to capture requirements and validate solution functionality.
• Troubleshoot system issues, instrument communication problems, and method validation discrepancies.
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity principles during system design and configuration.
• Support deployment, user acceptance testing (UAT), and training activities at global lab sites.

Required Skills & Experience:
• Hands-on experience with BIOVIA OneLab Foundation 2023 SP2 or recent versions .
• Proven experience in configuring, customization and deploying workflow-based lab processes in OneLab.
• Strong understanding of analytical test methods, assay protocols, and digitized lab processes.
• Familiarity with instrument connectivity standards (e.g., RS232, TCP/IP, OPC) and instrument data parsing.
• Ability to design and implement method templates and work instructions digitally.
• Good understanding of regulatory requirements for laboratory informatics systems.
• Strong experience with BIOVIA Pipeline Pilot for data processing and integration.
• Experience with BIOVIA other products – CISPRO, Compose & Capture.
• Ability to read and interpret lab SOPs and map them into digital workflows.
• Strong problem-solving skills and attention to detail.
• Excellent communication and documentation skills.

Preferred Qualifications:
• Degree in Pharmaceutical Sciences, Chemistry, Biotech, IT, or a related field.
• Experience in life sciences / pharmaceutical / chemical laboratory environments.
• Familiarity with BIOVIA Pipeline Pilot or scripting tools for data manipulation.
• Working knowledge of instrument vendor protocols (e.g., Empower, LabSolutions) and middleware like SDMS.
• Experience in CSV (Computer System Validation) and working in regulated (GxP) environments.