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LabWare LIMS & LEX Subject Matter Expert (SME)

ITSoli India Pvt Ltd.
Remote

Quick apply

Job details

Permanent | Full-time
Up to ₹30,00,000 a year
14 days ago

Benefits

Work from home

Qualifications

Computer Science
Incident management
Relational databases
Enterprise Software
Laboratory experience
Laboratory information management systems
Master's degree
Databases
SQL
Bachelor's degree
Application support
Business requirements
FDA regulations
Information Technology

Full job description

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.
Certifications in LIMS, Laboratory Informatics, GxP, Computer System Validation (CSV) or Life Sciences applications will be an added advantage.

Experience: Overall, 10+ years of experience, including 6+ years in Laboratory Information Management Systems (LIMS) within pharmaceutical, biotechnology, life sciences, laboratory and other regulated environments, with 5+ years of hands-on expertise in LabWare LIMS configuration, customization, enhancement, troubleshooting, implementation and production support, along with strong practical experience in LabWare LeX (Laboratory Execution System) and proven ability to collaborate effectively with cross-functional and global stakeholders in regulated environments.

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 ground breaking 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 a highly experienced LabWare LIMS & LeX Subject Matter Expert (SME) to provide functional and technical leadership for the design, configuration, implementation, support, troubleshooting and continuous improvement of LabWare LIMS solutions within a regulated Life Sciences environment. The SME will serve as a trusted technical and functional advisor to laboratory, IT, QA, validation and business teams; translate laboratory and business requirements into effective LIMS solutions; resolve complex application issues; and drive enhancements, testing, validation, releases and upgrades. The role also requires strong LabWare LeX expertise and the ability to train, coach and mentor team members while establishing and maintaining high standards of GxP compliance, data integrity and documentation.

Key Responsibilities:

Act as the Subject Matter Expert (SME) for LabWare LIMS and LeX, providing functional and technical guidance.
Lead LabWare LIMS configuration, customization, enhancements, troubleshooting and production support.
Translate laboratory/business requirements into effective LabWare LIMS solutions.
Troubleshoot complex LIMS issues, perform root-cause analysis and drive timely resolution.
Provide strong LabWare LeX expertise and support related laboratory execution processes.
Lead/support LIMS testing, validation, releases, upgrades and deployment activities.
Ensure LIMS solutions comply with GxP, CSV, data integrity and regulatory requirements.
Collaborate with laboratory, QA, validation, IT and business stakeholders to deliver solutions.
Design and deliver LabWare LIMS & LeX training, coaching and knowledge-transfer programs.
Develop and maintain SOPs, work instructions, training materials and technical/functional documentation.

Required Skills:

5+ years of hands-on experience in configuration, customization, enhancement, troubleshooting and production support.
Strong practical expertise in LabWare LeX and laboratory execution processes.
Proven ability to gather laboratory/business requirements and translate them into effective LIMS solutions.
Strong expertise in incident management, root-cause analysis, defect resolution and application support.
Strong working knowledge of GxP, Computer System Validation (CSV), data integrity and regulatory compliance.
Experience with LIMS testing, validation, releases, upgrades, enhancements and deployments.
Proven ability to train, mentor and collaborate effectively with laboratory, IT, QA, validation and global stakeholders.

Desired Skills:

Strong hands-on expertise in LabWare LIMS configuration, customization, enhancement, troubleshooting and LeX functionality.
Experience with SQL, relational databases and integrations with laboratory instruments, ELN, ERP, SDMS or other enterprise applications.
Proven experience in LIMS implementations, migrations, version upgrades and global rollouts.
Strong knowledge of GxP, GAMP 5, CSV, FDA 21 CFR Part 11 and data integrity requirements.
Experience developing SOPs, work instructions, user guides and training content, with strong mentoring and knowledge-transfer capabilities.

Personal Attributes:

Takes end-to-end responsibility for LabWare LIMS activities and outcomes.
Demonstrates strong troubleshooting, critical thinking and root-cause analysis capabilities.
Communicates effectively with technical, laboratory, QA, validation and business stakeholders.
Effectively trains, mentors and coaches team members while sharing SME knowledge.
Maintains a strong focus on documentation, data integrity, GxP compliance and quality standards.

Pay: Up to ₹3,000,000.00 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 LeX (Laboratory Execution System):: 2 years (Required)
LabWare LIMS: 5 years (Required)

Shift availability:

Overnight Shift (Required)
Night Shift (Preferred)

Work Location: Remote

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