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 / Formal LabWare Training — Required for the role.
- GxP / Computer System Validation (CSV) Training or Certification — Preferred for the role.
- GAMP 5 Certification / Training — Preferred for the role.

Experience: 10+ years of overall experience, including 6+ years in LIMS within Pharmaceutical, Biotechnology, Life Sciences or other regulated environments, with 5+ years of hands-on experience in LabWare LIMS configuration, customization, enhancement, troubleshooting, implementation and production support. Exposure to LabWare LeX or related laboratory execution, workflow automation, ELN or digital laboratory capabilities is preferred, with strong experience collaborating with cross-functional and global stakeholders.

Work Location: Remote (India) - Working in collaboration with US Service Delivery Team, supporting US Biopharmaceutical clients.

Work Timing: Must be willing to work in full-time US (PST) business hours.

Client Brief: A pioneering US 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 an experienced LabWare LIMS SME to provide functional and technical leadership for the design, configuration, implementation, support and continuous improvement of LabWare LIMS in a regulated Life Sciences environment. The role will also support the adoption and evolution of LabWare LeX and laboratory execution capabilities, working closely with laboratory, IT, QA, validation and business teams to deliver compliant and effective digital laboratory solutions.

Key Responsibilities:

- Act as the functional and technical SME for LabWare LIMS, providing guidance on laboratory informatics solutions.
- Lead LabWare LIMS configuration, customization, enhancements, troubleshooting and production support.
- Translate laboratory and business requirements into effective LabWare LIMS solutions and digital workflows.
- Support LabWare LeX / Laboratory Execution workflows, including requirements analysis, process design and solution enhancement.
- Lead/support LIMS testing, validation, releases, upgrades, migrations and deployments while maintaining GxP and data integrity compliance.
- Collaborate with laboratory, QA, validation, IT, business stakeholders and vendors to deliver effective solutions and resolve complex issues.
- Develop documentation and provide training, coaching and knowledge transfer to team members and end users.

Required Skills:

- Strong hands-on experience with LabWare LIMS configuration, customization, enhancement, troubleshooting and production support.
- Strong understanding of laboratory workflows and LIMS functionality.
- Experience gathering laboratory/business requirements and translating them into effective LIMS solutions.
- Strong incident management, troubleshooting, root-cause analysis and defect resolution skills.
- Experience with LIMS testing, validation, releases, upgrades and deployments.
- Working knowledge of GxP,



Computer System Validation (CSV), data integrity and regulatory compliance.
- Robust communication, stakeholder management and collaboration skills.
- Ability to work effectively with laboratory, IT, QA, validation and global stakeholders.

LabWare LeX / Laboratory Execution:

- · Exposure to LabWare LeX is preferred but extensive years of LeX-specific experience are not mandatory.
- · Experience with laboratory execution, guided workflows, workflow automation, ELN or digital laboratory initiatives will be considered relevant.
- · Candidates with strong LabWare LIMS expertise and the ability to learn and support emerging LeX capabilities will be considered.
- · Ability to translate existing laboratory processes into digital execution workflows is highly desirable.

Desired Skills:

- Exposure to LabWare LeX is preferred but extensive years of LeX-specific experience are not mandatory.
- Experience with laboratory execution, guided workflows, workflow automation, ELN or digital laboratory initiatives will be considered relevant.
- Candidates with strong LabWare LIMS expertise and the ability to learn and support emerging LeX capabilities will be considered.
- Ability to translate existing laboratory processes into digital execution workflows is highly desirable.

Personal Attributes:

- Strong troubleshooting, critical-thinking and root-cause analysis capabilities.
- Excellent communication and stakeholder management skills across technical, laboratory, QA, validation and business teams.
- Strong ownership, adaptability and willingness to learn emerging laboratory execution technologies such as LabWare LeX.
- Strong focus on documentation, data integrity, GxP compliance and quality standards.

Pay: Up to ₹3,000,000.00 per year

Benefits:

- Work from home

Experience:

- Exposure to LabWare LeX or related laboratory execution: 1 year (Required)
- Laboratory Informatics & Regulated Life Sciences environment: 10 years (Required)
- LabWare LIMS (Development, Support & Implementation): 5 years (Required)

Shift availability:

- Night Shift (Preferred)
- Overnight Shift (Required)

Work Location: Remote

📌 LabWare LIMS & LEX Subject Matter Expert (SME) (India)
🏢 ITSoli India
📍 India