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
• 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.