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Senior LabWare LIMS Specialist (Validation / Integration / Configuration)
Location: Thousand Oaks, CA (Hybrid – 3 Days Onsite per Week)
Duration: 12+ Months Contract
Position Overview
Takeda is seeking experienced LabWare LIMS Specialists to support ongoing laboratory informatics initiatives within a regulated pharmaceutical environment. We are open to candidates with expertise in one or more of the following areas:
· LabWare LIMS Validation
· LabWare LIMS Integration
· LabWare LIMS Configuration
This is a hands-on role requiring strong experience with LabWare LIMS. Candidates must have direct, recent experience working with LabWare LIMS in pharmaceutical, biotechnology, or life sciences organizations.
Important: LabWare LIMS experience is mandatory. There are no alternative technologies or substitute skill sets that will be considered.
Key Responsibilities
LabWare LIMS Configuration & Administration
· Configure and maintain LabWare LIMS modules, workflows, forms, master data, and business processes.
· Gather and analyze business and laboratory requirements.
· Support system enhancements, upgrades, and deployments.
· Develop and maintain technical and functional documentation.
· Troubleshoot application issues and provide ongoing system support.
LabWare LIMS Integration
· Design, develop, and support integrations between LabWare LIMS and enterprise applications.
· Build and maintain interfaces with systems such as SAP, ERP, MES, ELN, and laboratory instruments.
· Develop and support APIs, web services, database integrations, and data migration activities.
· Troubleshoot integration and data flow issues across multiple systems.
· Ensure data integrity, security, and compliance requirements are met.
Computer System Validation (CSV)
· Develop and execute validation documentation and protocols.
· Prepare Validation Plans, URS, Functional Specifications, IQ/OQ/PQ documentation, Traceability Matrices, and Validation Summary Reports.
· Support testing activities and validation lifecycle management.
· Ensure compliance with FDA, GxP, GAMP 5, and 21 CFR Part 11 requirements.
· Participate in audits, inspections, and quality reviews.
Required Qualifications
· 5+ years of hands-on experience with LabWare LIMS.
· Strong experience in at least one of the following:
o Validation
o Integration
o Configuration/Administration
· Experience working in pharmaceutical, biotechnology, medical device, or life sciences environments.
· Knowledge of laboratory operations and laboratory informatics systems.
· Strong understanding of SDLC and system implementation methodologies.
· Excellent troubleshooting, analytical, and communication skills.
· Ability to work effectively with business users, laboratory teams, quality teams, and technical stakeholders.
Preferred Qualifications
· Experience with FDA-regulated and GxP-compliant environments.
· Knowledge of 21 CFR Part 11, Data Integrity, and GAMP 5.
· Experience integrating LabWare LIMS with SAP, MES, ELN, or laboratory instruments.
· SQL and database experience.
· Previous experience supporting large-scale LabWare implementations and upgrades.
If you have strong LabWare LIMS expertise in Validation, Integration, Configuration, or a combination of these areas,
Thanks:
GAURAV VISHWAKARMA
IT Recruiter (Sibitalent Corp)
Office – 101 E. Park Blvd,Suite 600, Plano, TX–75074
Phone: 936-297-2002
