Role Summary


The LIMS Developer will perform configuration, development, and validation activities to support LabWare LIMS enhancements to interface with lab instruments. The ability to configure and program in LabWare LIMS is required.


Responsibilities:


• Develop and implement improvements

• Develop interface to integrate field instruments e.g. Ramen NIR handheld units, pH meters,  Balances etc

• Develop Electronic Test Records in LIMS 

• 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


Experience:


• 3+ years experience supporting and implementing as a LabWare LIMS developer

  • Experience in pharmaceutical QC or Research Lab environment for 3 years
  • Demonstratable experience of working in LIMS pharmaceutical QC or Research Lab
  • Experience developing in LabWare LIMS v6 and above in a GxP environment

• Experience with LabWare LIMS/ELN configuration, LabWare LIMS Basic, Labstation

• Knowledge of relational databases and SQL queries

• Crystal Reports development skills

• Firm understanding of computer system validation, GMP predicate rules, 21CFR Part 11/EU Annex 11, and Data Integrity concepts

• Experience with application deployment methodologies in a regulated environment (GAMP 5, Risk Analysis, Waterfall, Agile & Rapid development methodologies, etc.)

• Clear verbal and written communication skills to provide customers with a positive experience


Preferred: 


• Raman configuration skills

• Basic programming knowledge in any language

• Trackwise experience

• Experience with HP ALM or equivalent software testing/requirements tools

• GxP benchtop instrument experience



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