I'm recruiting for a GLIMS Specialist in a leading Bio-Pharmaceutical company, in Dublin. This role will be fully remote.
The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in static data management within the LIMS platform, complete and review change requests, validate configurations, provide user support, and troubleshoot as needed. S/he will be responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, distributed team environment, and communicate effectively is essential to success.
This position is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures and global data standards.
*Fully remote
*11 month contract
REQUIRED SKILLS
- Bachelor's Degree or higher in Chemistry, Biological or Computer Science
- A minimum of 4 years of LIMS hands-on experience in a pharmaceutical environment with LabWare LIMS v6 (or higher) static data configuration including developing analyses, product specifications, and calculations.
- In depth knowledge and experience on the Labware LIMS modules, primarily Stability, Lot Management, Standards and Reagents, Environment Monitoring, Project Manager, Storage Location manager, and use of Querying tools.
- Familiarity and/or experience with Labware LIMS Basic to build/update calculations.
- Candidate must have knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
- Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
- Possesses the ability to translate Standards (Data/Process) and "Digital transformation" vision into execution projects
- Exhibit ability to learn new features and functions in LIMS and related systems and can increasingly handle more complex issues and requests
- Ability to build and run SQL queries for Ad hoc reporting/querying
PREFERRED SKILLS
- Experience using Microsoft Word and Excel
- Familiarity with other systems (E.g. SAP, Crystal Reports, Documentation Repositories, Electronic Testing Tools)
- Ability to write UAT scripts and support execution of UAT adhering to SDLC
- Provide inspection support (input into storyboarding, understanding the query, articulate findings)
- Programming experience (E.g. SQL, LIMS Basic)
- Ability to build and run SQL queries for Ad hoc reporting/querying
- Ability to translate Standards (Data/Process) and "Digital transformation" vision into execution projects
