Johnson & Johnson Vision Care Ireland is located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 900 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.
Johnson & Johnson Vision Care Ireland was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 31 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.
Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.
The LIMS Engineer role encompasses responsibility in supporting the supervisor role in the Management of LIMS to ensure work is being completed to support projects.
· Works on complex LIMS configurations to meet requirements of LIMS users.
· Responsible for LIMS documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports.
· Process LIMS change control requests.
· Works with the laboratory and field personnel to optimize LIMS functions for the laboratory
· Analyzes data trending generated by LIMS 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 projects using project management tools to ensure project timeliness and completion.
· Train others as appropriate on specific area of LIMS 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 change control process through timely resolution of incident tickets
· Lead cross-functional meetings to track status of LIMS 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
· 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
Education and Experience Required for Role
· Degree Qualified with 3-5 years relevant LIMS 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.
· Excellent IT skill e.g. experience in minitab, excel reports. Empower knowledge
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Vision Care (Ireland) Limited (8182)