Associate Engineer- LIMS

Job description

Associate Engineer- LIMS

1. Job Purpose:
Short statement stating exact purpose of the role:
The Associate Engineer LIMS role encompasses responsibility in supporting the supervisor role in the Management of LIMS/Empower activity to ensure work is being completed to support projects.

2. Responsibilities:
• Works on complex LIMS/Empower configurations to meet requirements of LIMS/Empower users.
• Responsible for LIMS documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports.
• Process LIMS/Empower change control requests.
• Works with the laboratory and field personnel to optimize LIMS/Empower functions for the laboratory
• Analyzes data trending generated by LIMS/Empower for process improvement purposes and general Lab process improvement projects.
• Identify, analyze, propose, and document appropriate solutions for problems and issues that can improve the laboratory information management process; understand and follow appropriate quality validation processes and application processes.
• Track all LIMS/Empower projects using project management tools to ensure project timeliness and completion.
• Train others as appropriate on specific area of LIMS/Empower expertise; assist in development of systems documentation and training materials and training processes.
• Coordinate system maintenance downtime needs between user community and system support personnel
• Lead and mentor on best practices regarding data integrity, corporate data management of GxP data
• Manage GMP training as it pertains to laboratory systems and data.
• Provide first level diagnosis and troubleshooting of incidents to support business users
• Manage the LIMS/Empower change control process through timely resolution of incident tickets
• Lead cross-functional meetings to track status of LIMS/Empower change requests and project status
• Support lab users and vendors with analytical equipment qualification and validation to ensure data integrity per the relevant standards (21 CFR Part 11)
• Provides end-to-end support for tickets requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution)
• Acts as liaison between internal laboratory users and vendor to address various system issues Evaluates product enhancements and capabilities, in addition to implementing upgrades as required
• Administer security changes to the LabWare LIMS, including creation of new user accounts, changing security levels as authorized, maintaining appropriate documentation
• Develop IQ/OQ/PQ test scripts to support validation of new functionality
• Partner with the software quality department to support validation activities
• Support the training of new users, including creation of training material and SOPs
As appropriate:
• Maintaining and supporting current CDS system
• End user issue support, troubleshooting, & resolution
• Provides assistance in the creation of maintenance release enhancements
• Integrate instruments
• Performs entry and edit of all relevant static data

Desired profile

Education and Experience Required for Role
Essential:
− Degree Qualified with 3-5 years relevant LIMs/Empower experience in Medical Devices/Pharmaceutical Industry
− Proven knowledge in system testing, validation, problems resolution, and training.
− Excellent oral and written communication skills.
− Customer services oriented, flexible and ability to apply good judgment.
− Detail oriented and ability to work in a team environment.
− Ability to work under pressure and troubleshoot problems.
− Ability to follow multiple projects from beginning to completion.
− Ability to interpret test results and prepare reports.
Desirable:
− Excellent IT skill e.g. experience in minitab , excel reports. Empower knowledge