27 Aug
|
ITSoli India
|
India
27 Aug
ITSoli India
India
Designation: LabWare LIMS & LeX Subject Matter Expert (SME)
Qualification: Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, Chemistry, Biotechnology or a related discipline. Equivalent relevant experience in Laboratory Information Management Systems (LIMS) may also be considered.
Certifications:
- Labware LIMS certification/training is preferred.
- Relevant certifications in LIMS, Laboratory Informatics, GxP, CSV or Life Sciences applications are an added advantage.
Experience: Overall 6 years of experience in a laboratory, pharmaceutical, biotechnology or other regulated environment, including a minimum of 4 years of hands-on experience with LabWare LIMS and working knowledge of LeX (Laboratory Execution System).
Work Location & Timing: Remote (India) - Working in collaboration with US Service Delivery Team, supporting US Biopharmaceutical clients. Must be willing to work in full-time US (PST) business hours.
Client Brief: A pioneering biopharmaceutical leader, the client organization is driven by a mission to discover, develop and deliver transformative therapies that improve the lives of people around the world. With a deep focus on innovation, they have introduced groundbreaking treatments across areas such as virology, oncology and inflammation. Their trailblazing work has contributed to global advancements in HIV treatment and the fight against viral diseases.
Recognized for a robust pipeline and a legacy of scientific excellence, they continuously invest in cutting-edge research and strategic partnerships. Their commitment to access, sustainability and patient-centric innovation has earned them accolades as one of the most admired and socially responsible companies in the healthcare industry.
Job Role: We are seeking an experienced LabWare LIMS Subject Matter Expert (SME) to provide functional and technical expertise in the design, configuration, implementation, support and continuous improvement of LabWare LIMS solutions within a regulated Life Sciences environment. The SME will act as a key point of contact for LabWare LIMS-related activities, collaborate with business and technical stakeholders,
troubleshoot complex application issues and support application enhancements. A strong understanding of LabWare LeX is essential, with the capability to train, coach and enable fellow employees on the LabWare LIMS application and associated processes.
Key Responsibilities:
- Serve as the Subject Matter Expert (SME) for LabWare LIMS, providing functional and technical guidance to project, support and laboratory teams.
- Perform LabWare LIMS configuration, customization, enhancement, troubleshooting and application support.
- Demonstrate strong LeX expertise and act as the primary knowledge resource for LeX-related LabWare LIMS capabilities.
- Design and deliver training sessions on LabWare LIMS and LeX to fellow employees, including new-hire and refresher training.
- Gather and analyse business/laboratory requirements and translate them into effective LabWare LIMS solutions.
- Troubleshoot complex LIMS issues, conduct root-cause analysis and drive timely resolution of incidents and defects.
- Support LIMS testing, validation, releases, upgrades, enhancements and deployment activities in a regulated workplace.
- Ensure LabWare LIMS solutions comply with GxP, data integrity, CSV and applicable regulatory requirements.
- Develop and maintain SOPs, work instructions, training materials, system documentation and knowledge repositories.
- Mentor junior team members and collaborate with laboratory, QA, validation, IT and business stakeholders to drive continuous improvement of LabWare LIMS capabilities.
Required Skills:
- 4 years of hands-on experience in LabWare LIMS configuration, customization, enhancement, troubleshooting and support.
- Strong and practical knowledge of Labware LeX, with the ability to use and explain its capabilities effectively.
- Proven ability to train,
coach and mentor employees on LabWare LIMS and LeX functionality.
- Strong understanding of laboratory workflows, LIMS processes, requirements gathering and solution design.
- Working knowledge of GxP, CSV, data integrity and regulated Life Sciences environments.
- Strong analytical skills with experience in LIMS troubleshooting, root-cause analysis, configuration, testing and issue resolution.
- Excellent communication and collaboration skills with the ability to work effectively with laboratory users, IT, QA, validation and global stakeholders.
Desired Skills:
- Experience with SQL, relational databases, data queries and troubleshooting LIMS database-related issues.
- Experience integrating LabWare LIMS with laboratory instruments, ELN, ERP, SDMS or other enterprise applications.
- Experience supporting LIMS implementations, migrations, version upgrades and global rollouts.
- Additional knowledge of GAMP 5, FDA 21 CFR Part 11, data integrity and computerized system validation (CSV) practices.
- Experience creating SOPs, work instructions, training content, user guides and LIMS knowledge repositories.
Personal Attributes:
- Accountability, takes ownership of LabWare LIMS activities and acts as a trusted subject matter expert.
- Strong ability to train, coach, mentor and transfer knowledge effectively to fellow employees.
- Strong troubleshooting, critical-thinking and root-cause analysis skills for complex LIMS issues.
- Communicates clearly and works effectively with technical, laboratory, QA, validation and business stakeholders.
- Highly detail-oriented with a strong commitment to documentation, data integrity, GxP compliance and quality standards
Pay: Up to ₹2,500,000.00 per year
Benefits
- Work from home
Application Question(s):
- How many years of experience in providing training / knowledge transfer on LabWare LIMS and LeX to employees or end users?
Experience:
- LabWare LIMS: 4 years (Required)
- LabWare LeX (Laboratory Execution System):: 2 years (Required)
Shift availability:
- Overnight Shift (Required)
- Night Shift (Preferred)
Work Location: Remote
📌 LabWare LIMS & LEX Subject Matter Expert (SME) (India)
🏢 ITSoli India
📍 India