The LIMS Developer will perform configuration, development, and validation activities to support LabWare LIMS enhancements. The ability to configure and program in LabWare LIMS is required.
• Develop and implement improvements
• Propose technical solutions and architectures
• Support validation activities
• Develop Functional Requirements and Configuration Specifications
• Manage iterative development of system as needed to ensure system meets business needs
• Work closely with CSV personnel to develop risk appropriate testing strategy.
• Maintain current knowledge of industry standards and regulatory requirements for computerized systems
Skills & Experience Required:
• 3 years’ experience supporting and implementing Enterprise application(s) as a LabWare LIMS developer • LabWare LIMS/ELN configuration skills and LabWare LIMS Basic
• Firm understanding of computer system validation, GMP predicate rules, 21CFR Part 11/EU Annex 11, and Data Integrity concepts
• Clear verbal and written communication skills to provide customers with a positive experience
• Knowledge of relational databases and SQL queries
• Crystal Reports development skills
• Basic programming knowledge in any language
• Trackwise experience
• Raman configuration skills
• Experience with HP ALM or equivalent software testing/requirements tools
• Experience with application deployment methodologies in a regulated environment (GAMP 5, Risk Analysis, Waterfall, Agile & Rapid development methodologies, etc.)
• Bachelor’s Degree preferably in Computer Science or Life Sciences. Equivalent experience may be considered.