Extelligence is an intelligent partner that goes the extra mile. We provide customized information management solutions for major industries. Our team in Prague and Bucharest is working with international companies, transforming, and adding value to their business on a daily basis. We are growing quickly, and we are interested to bring more talented individuals into our team.
We are looking for a LIMS Validation expert. The role requires the candidate to have validation/testing experience on LIMS application (preferably on Labware LIMS)
Responsibilities
- Understanding of dynamic and static data in LIMS.
- Understanding the functional requirements captured during the project phase (requirements for LIMS modules such as Lot manager, Stability management, reagent management,
- Environmental monitoring etc.)
- Understanding the functional requirements created for interfaces such as Empower, SAP PM, Reliance, LabX etc. (good to have)
- Preparation of new or update existing test data (dynamic and static data) in LIMS as part of test preparation.
- Draft all SDLC deliverables – User requirement specs, design & configuration specs, development testing, Summary report, traceability matrix, UAT etc.
- Writing test cases/scripts based on the requirements gathered.
- Review of test documents.
- Actual execution of test scripts during the stipulated timeframe.
- Report the testing progress to Test Manager on daily basis.
- Report/escalate issues as needed to test Manager and CoE Lead
- Work closely with the LIMS CoE development team.
- Work closely with site Admins (SPOCs) and support them for static data creation and troubleshooting.
- Understand the enhancements and changes planned for end users and demo those changes to end users.
- Participate in Community of Practice (COP) meetings every week with site users and LIMS project team.
- Deliver functional DEMOs of interfaces, LIMS features & functionalities to site users.
LabWare LIMS Business Support & Maintenance
- Support the Labware global roll-out as agreed with quality leadership.
- Partner with the functional areas, supporting the Global business process in the LIMS system.
- Contribute to the development of site SMEs and peers.
- Ensure that the validated status of global LIMS is maintained through the system’s lifecycle.
- Primary contact for site Admins (SPOCs) in case of errors, problems, best practices, and requests for LIMS
- Share and communicate LIMS knowledge.
- Review system issues and ensure they are escalated as appropriate.
- Contribute to the global LIMS SOPs and Training modules as needed.
Experience, Knowledge & Skills:
- Knowledge of validation/ ALM systems such as eVAL/Kneat and collaboration tools like Confluence/JIRA.
- Experience in working closely with end-user at QC labs and LIMS development/project teams.
- Knowledge of how integration/interfaces work between LIMS and other system(s) e.g., SAP PM, LabX, Reliance, Empower etc.
- Experience working in large, multiyear projects in complex operating environments where consistent attention to details is critical.
- Excellent communication skills (written and oral) and highly collaborative
- Excellent ability to coordinate with multiple stakeholders.
- Self-starter person who gets the tasks done
- Excellent team player
Qualifications & Education:
- A minimum of a bachelor’s degree in a technical discipline or equivalent.
- Minimum 3+ years of Labware LIMS testing/validation experience.
- Someone who has worked in QC labs as a LIMS end user (Preferred but not mandatory).
Working with Extelligence:
- We take care of the important things that matter to contractors, for example, we guarantee on-time payment for your work. You will never have to chase us for payment.
- We always seek to have long term relationships with our team and we always seek to offer opportunities to extend cooperation beyond the first contract or project.
- Extelligence is a multicultural team, we have more than 15 different nationalities working with us.
- We also organize events to bring our team together including team building activities and social events.