Req. #:

12808

Position:

LabWare LIMS Developer

Business:

Pharmaceuticals

Location:

Spring Valley, NY

Duration:

6 months+

Project Description:

The consulting position is responsible for LabWare LIMS development, primarily related to configuration and coding of enhancements to an existing LabWare LIMS v.5 implementation.
Consultant responsibilities include configuration, programming and maintenance of LabWare LIMS.

Primary duties include business process analysis and requirements gathering, solutions design, software quality assurance, documentation according to a defined Validation Master Plan, automation via configuration, scripting, programming and support. The work envisaged may require that the consultant work on several changes concurrently. The consultant must have strong communication skills and will be in direct discussions with users and IT personnel.

Duties and responsibilities:
- Designs, documents, and implements updated and new LIMS functionality according to business requirements (80%)
- Provides support for LIMS changes. Documents all issues related to system design and configuration (10%)
- Trains users in the operation of new or updated functionality (5%)
- Other assignments as required (5%)

Required Skills:

Requirements:
- LabWare LIMS v5 configuration and administration, including LIMS Basic Crystal Reports
- Computer Systems Validation and thorough knowledge of 21 CFR Part 11 guidelines
- Familiarity working in a GxP environment
- Change management processes

Education/Experience:
The consultant must possess a sufficient knowledge of FDA-regulated computer systems so as to both rigorously evaluate requirements and specify appropriate designs to meet the requirements. This consultant must have at least two (2) years experience working with and configuring LabWare LIMS v5. The consultant must have a thorough knowledge of LIMS as used in a pharmaceutical laboratory environment. Knowledge of current Good Manufacturing Practices and Standard Operating Procedures, and 21 CFR Part 11 guidelines is necessary.

Desired Skills:
- Knowledge of / experience with TrackWise Quality Management System
- Knowledge of / experience with Empower Chromatography Data System
- Developing XML-based reports
- Structured Query Language (SQL)

Other Information:

Our client has a number of LIMS enhancements slated for implementation in 2010. For each enhancement request, our client requires full time, dedicated LIMS developer(s) for configuration of the enhancement. Enhancements may be implemented individually, simultaneously or sequentially based on priority, complexity of the change and an agreed implementation schedule between our client and the consultant. The consultant may be based on site or remotely as needed within the guidelines set out above, i.e. that they be dedicated full time to our client for the duration of time required to configure a given enhancement. Our client will provide the consultant with a laptop and all necessary software for execution of the job functions described above.