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Lims Sme Jobs (NOW HIRING)

Xyntek Inc.

Automation SME

Gaithersburg, MD · On-site

The SME works closely with engineering, manufacturing, quality,validation, and system integration ... Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, processhistorians, MES/LIMS ...

Bnh Jv

$66 - $90/hr

Facility Chem Lab SME Location: Arnold AFB, TN Job Family Code: R-Scientific Research & Analysis ... System (LIMS). This job is a working supervisor, supervising the lab operations while at times ...

Guidehouse

QA Regulatory Data SME

$85K - $141K/yr

The SME will assess data quality, validate adherence to FDA standards, and provide actionable ... Knowledge of database systems used for laboratory data management (e.g., LIMS), scientific ...

Guidehouse

QA Regulatory Data SME

$85K - $141K/yr

The SME will assess data quality, validate adherence to FDA standards, and provide actionable ... Knowledge of database systems used for laboratory data management (e.g., LIMS), scientific ...

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Lims Sme information

What is a LIMS SME?

A LIMS SME, or Laboratory Information Management System Subject Matter Expert, is a professional who specializes in the implementation, configuration, and optimization of LIMS software within laboratory environments. They provide expertise on how to best use the system to support laboratory workflows, ensure data integrity, and comply with regulatory standards. LIMS SMEs often act as a bridge between laboratory staff, IT, and software vendors to translate business requirements into technical solutions. Their role may also include training users, troubleshooting issues, and supporting system upgrades or validations.

What are the key skills and qualifications needed to thrive as a LIMS SME?

To thrive as a LIMS Subject Matter Expert (SME), you need in-depth knowledge of laboratory processes, data management, and a strong background in life sciences or information technology. Expertise in Laboratory Information Management Systems (LIMS), familiarity with database management, and relevant certifications such as LIMS vendor training are highly valuable. Excellent problem-solving abilities, communication skills, and the ability to translate technical requirements for non-technical stakeholders set top candidates apart. These skills are essential for successfully implementing, maintaining, and optimizing LIMS solutions that support laboratory efficiency and regulatory compliance.

What are some common challenges faced by a LIMS SME when implementing a new Laboratory Information Management System in a regulated environment?

A LIMS SME often encounters challenges such as aligning system functionalities with complex laboratory workflows, ensuring data integrity and compliance with regulatory requirements (like FDA 21 CFR Part 11), and managing change resistance among lab staff. Additionally, integrating the LIMS with existing instruments and IT infrastructure can require extensive collaboration with cross-functional teams. Successfully navigating these challenges typically involves thorough requirements gathering, effective stakeholder communication, and providing comprehensive user training throughout the implementation process.

What is the difference between Lims Sme vs Laboratory Technician?

AspectLims SmeLaboratory Technician
CredentialsRelevant certifications, often in laboratory information management systems (LIMS)Typically requires a degree in science or related field
Work EnvironmentOffice-based, system management, and support roles within labsHands-on laboratory work, sample processing
Employer & IndustryPharmaceutical, biotech, and clinical labs using LIMSResearch labs, clinical labs, manufacturing
Search & Comparison IntentUnderstanding roles in LIMS management and supportLaboratory procedures and sample handling

The Lims Sme focuses on managing and supporting laboratory information systems, requiring technical knowledge of LIMS software and system integration. In contrast, a Laboratory Technician performs hands-on sample analysis and laboratory tasks. While both roles are essential in lab environments, the Lims Sme is more system-oriented, whereas the Laboratory Technician is more operational and experimental.

What cities are hiring for Lims Sme jobs?

Cities with the most Lims Sme job openings:

What states have the most Lims Sme jobs?

States with the most job openings for Lims Sme jobs include:

What are popular job titles related to Lims Sme jobs?

For Lims Sme jobs, the most frequently searched job titles are:

Infographic showing various Lims Sme job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 93% Full Time, 2% Part Time, and 4% Contract. Highlights an 79% Physical, 5% Hybrid, and 16% Remote job distribution.

Automation SME

Gaithersburg, MD • On-site

Xyntek Inc.
11 - 50 employees
Learn more about Xyntek Inc.external

Other

Posted 11 days ago

Job description

Gaithersburg, United States | Posted on 08/03/2026

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai .

Job Description

Catalyxis seeking an Automation Subject Matter Expert (SME) provides technicalleadership for the design, implementation, validation, and lifecycle support ofautomation systems supporting biologics manufacturing operations. This roleensures automation solutions are reliable, compliant, secure, and aligned withindustry standards while supporting upstream and downstream processperformance. The SME works closely with engineering, manufacturing, quality,validation, and system integration teams to deliver scalable automation solutionsthroughout the project lifecycle.

Responsibilities
  • Provide technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, andclean utility systems.
  • Develop and review automation architecture, control strategies,functional specifications, batch recipes, and system design documentation.
  • Support automation deployment strategies, technology evaluations, anddigital manufacturing initiatives, including data integration and operationaloptimization.
  • Oversee system integration, commissioning, qualification, and validationactivities, including FAT, SAT, IQ/OQ, and commissioning support.
  • Ensure automation systems comply with GMP, GAMP 5, ISA-88, ISA-95, dataintegrity, cybersecurity, and other applicable regulatory standards.
  • Collaborate with cross-functional teams to define process controlrequirements, batch reporting, system interfaces, and operational readiness.
  • Support risk assessments, alarm management, cybersecurity, andautomation lifecycle management.
  • Provide technical guidance to vendors, system integrators, and internalengineering teams while promoting automation best practices and continuousimprovement.
Requirements
  • Bachelor's or Master's degree in Automation, Electrical, Controls,Chemical, Process Engineering, or a related technical discipline.
  • 8+ years of experience supporting automation systems in GMP biologics orpharmaceutical manufacturing environments.
  • Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, processhistorians, MES/LIMS integration, and industrial networking.
  • Hands-on experience with biologics manufacturing processes, includingbioreactors, chromatography, UF/DF, filtration, CIP/SIP, and clean utilities.
  • Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+,computerized system validation (CSV), and data integrity principles.
  • Experience leading automation system design, commissioning,qualification, troubleshooting, and lifecycle support.
  • Excellent communication, technical leadership, and cross-functionalcollaboration skills.
  • Preferred certifications include ISA CAP, GAMP, Functional Safety, orrelevant automation platform certifications.
Why Join Catalyx?

At Catalyx we understand that our people are our greatestasset. For this reason and many others, we take care of them. The team inCatalyx benefits from a Total Rewards package. This includes great personalbenefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committedto creating a diverse and inclusive workplace where all individuals are valued,respected, and supported. We do not discriminate on the basis of race, color,religion, sex (including pregnancy, gender identity, and sexual orientation),national origin, age, disability, veteran status, genetic information, or anyother characteristic protected by applicable law. We encourage applicationsfrom all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

At Catalyx, we are committed to attracting the best globaltalent. We proudly support our international employees by offering assistancewith Critical Skills Visa applications for eligible candidates.

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