The qualified individual will utilize a basic knowledge of informatics to support R&D laboratories through development, support, and validation of computer systems. A basic foundation in the software development lifecycle is needed and a general knowledge of computer programming languages, such as LabWare LIMS Basic, C++, Java, .NET, SAS, PHP, ColdFusion, SQL, and/or other web scripting languages. The individual will drive activities around computer programming, system administration, and support of computer systems used within clinical testing operations. These activities, which include software validation, will focus on collecting business requirements, converting them to functional solutions, validating the solutions, and deploying them into a production environment.
The individual will have strong communication skills, have the ability to take direction and work independently, meet tight deadlines, coordinate activities across groups, train end-users, and assist with improving large scale processes. The individual will be expected to contribute to technical tasks by taking close direction.
Most of the activities performed follow GxP regulations, so an understanding of Quality processes and their relation to software administration, documentation, and programming is necessary. The individual will have a strong passion for innovation and all the activities that are associated, especially in adding efficiencies to subroutines and performance of algorithms. Some projects may require collaboration with statisticians to develop robust algorithms that analyze data.
- Use computer science/information systems/life sciences knowledge in order to design, build, configure, program, and/or validate computer code, master data, reports, forms, and interfaces.
- Write/update departmental SOPs, maintain technical paperwork, and migrate such data to archive repository.
- Analyze user requirements, models, and specifications in order to convert them to technical solutions.
- Contribute to activities around debugging and testing of any solutions.
- Participate in validation activities, specifically around development of test scripts and other GxP documentation generated during system support and validation.
- Follow change management processes for routine changes, for example routine change controls.
- Provide day-to-day end-user support and take a leadership role in monitoring “help desk” support queue.
- Write and execute ad-hoc SQL queries.
- Satisfactorily complete all cGMP/GLP and safety training in conformance with departmental requirements.
- BS/BA in Computer Science, Information Systems, Life Sciences, or a related Computational Field with 0-2 years experience or MS/MA in similar backgrounds.
- Software certifications in IT related courses, specific experience/certificates in LabWare LIMS Basic, or an understanding of web development technologies (for example SharePoint and/or scripting languages), is strongly suggested.
- Deep knowledge of various programming languages, computer architecture, and/or algorithms, preferred.
- Experience with designing, developing, and querying databases, preferred.
- Knowledge of the software validation lifecycle, preferred.
- Strong understanding of Excel and/or Access (and other database software), expected.
- Experience in analytics and/or data collection/processing through statistical software, preferred.
- Experience performing biological assays, a plus.
- Excellent written and verbal communication skills, required.
- Proven track record of managing deadlines and scheduling workload, required.
Work primarily performed at individual’s desk or may require walking around to various laboratories/biosuites. Will spend a great deal of time coding, analyzing data, and testing technical solutions.
Weekend/night work required on occasion when coordinating off hour system upgrades or weekend end-user support. Travel may be required to vendors or collaborative sites, as needed.