IT Laboratory Application Support Engineer

JOB SUMMARY
The IT Laboratory Application Support Engineer primary focus will be keeping and supporting our GMP applications that are running within our laboratory environments. The Enterprise software applications that are currently installed at BA Sciences include, but not limited to: LabWare LIMS, Crystal Reports, ETQ Reliance and Waters Empower System

PRIMARY DUTIES AND RESPONSIBILITIES

·        Work as a member of the LIMS support team, enhance and troubleshoot the LIMS and Empower systems, with opportunities to work with other development teams within the department.

·        Primary support will be LabWare LIMS product specification creation, testing and updates to existing product specifications.

·        Provide general LIMS administration support, resolving issues that come in through IT ticketing system or QMS change controls.

·        Responsible for LIMS specific scripting language calculations, based on products and tests performed, workflows, and schemas to continually meet the needs of the laboratories.

·        Support Computer Systems Validation efforts for both existing and new system implementations by ensuring proper CSV procedures are in place.

·        Create validation scripts / documents for GxP applications including Empower and LIMS

·        Administrate the Water Empower system, oversee management and day-to-day operations of the system, to ensure smooth and efficient operations.

·        Knowledge of Water Empower custom fields design and implementation of new processes or configurations based on business requirements.

·        Secondary support for creation, updates and maintaining Labware LIMS ELNs by following and understanding methods and SOPs.

·        Perform audits of GMP systems, collaborate and presents findings to management.

·        Create and support related documents, processes, and SOPs.

·        Acts as a liaison between internal laboratory users and vendors to address various systems issues and user requirements.

·        Participate in application upgrades, patching and maintenance initiatives.

·        Provide exceptional customer service to our internal employees.

REQUIREMENTS & QUALIFICATIONS

·        Bachelor’s degree in life science, physical science, or technology field with 10 years’ laboratory experience performing development functions for a GMP laboratory.

·        3 years’ experience within software development life cycle methodology

·        Worked within a regulated environment (Pharmaceuticals, Contract Laboratories, Biotech or other regulated fields)

·        Support and configuration support in both Labware LIMS & Water Empower systems is needed.

·        Extensive programming languages knowledge and experience for SQL, Json and python

·        Strong knowledge of Computer System Validation techniques and practices

·        Thorough knowledge of general routine laboratory operations and processes, with the ability to integrate those processes into a system electronic workflow.

·        Experience compendia methodology (USP, EP, JP etc....)

MINIMUM SKILLS REQUIREMENTS

·        Must be detail oriented and have good documentation practices.

·        Excellent process knowledge of Master Data generation in the Labware LIMS Environment.

·        Must have the ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently. 

·         Perform all assigned duties on time and can adapt to changing priorities.

·        A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel. 

·        Must have excellent organizational, verbal communication and technical documentation skills. 

·        Must be a team player with integrity and concern for the quality of company products, services, and staff members.

·        Perform all other assigned duties.