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Lims Validation Jobs (NOW HIRING)

The potential candidate will be responsible to upgrade the current version of the LIMS to the latest version and validate the upgrade. The candidate will be working with DGS IT resources and Abbott ...

Position Overview The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds ...

The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds compliant digital ...

New

The potential candidate will be responsible to upgrade the current version of the LIMS to the latest version and validate the upgrade. The candidate will be working with DGS IT resources and Abbott ...

As a Senior LabWare LIMS Developer we are looking for an individual to excel in the technical ... Design, development and testing and validation of LabWare coding and configuration to meet user and ...

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LIMS Validation information

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$22

$51

$78

How much do lims validation jobs pay per hour?

As of Sep 1, 2026, the average hourly pay for lims validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is LIMS validation?

LIMS validation is the process of ensuring that a Laboratory Information Management System (LIMS) meets regulatory requirements and performs as intended. This involves documented testing of the software to confirm its accuracy, reliability, and consistent intended performance in a specific laboratory environment. Validating a LIMS is crucial for compliance with standards such as FDA 21 CFR Part 11 or ISO 17025, and helps ensure data integrity and traceability. The process typically includes risk assessment, protocol development, execution, and documentation of results. Proper validation reduces the risk of errors and supports laboratory operations and audits.

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

To excel as a LIMS Validation Specialist, you need a strong background in laboratory processes, software validation, and knowledge of regulatory requirements, often supported by a degree in life sciences or IT. Familiarity with Laboratory Information Management Systems (LIMS), validation protocols (IQ/OQ/PQ), and tools like SQL or scripting languages is typically required. Attention to detail, problem-solving ability, and effective communication are crucial soft skills for ensuring compliance and collaborating with cross-functional teams. These competencies are vital to guarantee data integrity, regulatory compliance, and the successful implementation of LIMS in laboratory environments.

What are some common challenges faced when validating a Laboratory Information Management System (LIMS), and how can they be addressed?

One common challenge in LIMS validation is ensuring the system meets both regulatory compliance and the specific needs of the laboratory. This often requires close collaboration with IT, QA, and lab staff to gather and translate user requirements into testable validation protocols. Another challenge is managing software updates or customizations without disrupting validated processes. Staying organized with thorough documentation and leveraging validation templates can help streamline the process and ensure ongoing compliance. Open communication and regular training within the validation team are also key to addressing unexpected issues efficiently.

What is the difference between Lims Validation vs Lims Analyst?

AspectLims ValidationLims Analyst
CertificationsGxP, 21 CFR Part 11 compliance, validation certificationsGxP, 21 CFR Part 11 familiarity, relevant certifications
Work EnvironmentQuality assurance, validation teams, regulated labsLaboratories, data analysis, system monitoring
Industry UsagePharmaceutical, biotech, clinical labsLaboratory operations, data management

While Lims Validation focuses on ensuring Laboratory Information Management Systems meet regulatory standards through validation processes, Lims Analysts primarily handle data analysis, system monitoring, and supporting laboratory operations. Both roles require familiarity with GxP regulations, but Lims Validation is more specialized in validation procedures, whereas Lims Analysts focus on data integrity and system performance.

More about LIMS Validation jobs

What cities are hiring for Lims Validation jobs?

Cities with the most Lims Validation job openings:

What states have the most Lims Validation jobs?

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

Infographic showing various Lims Validation job openings in the United States as of August 2026, with employment types broken down into 93% Full Time, 3% Part Time, and 4% Contract. Highlights an 85% Physical, 5% Hybrid, and 10% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Computer System Validation (CSV) Engineer

Kashiv BioSciences, LLC

Piscataway, NJ

$65 - $75/hr

Full-time

Re-posted 23 hours ago


Job description

Description


Position Type: Full-time Employee (FTE)

Location: Piscataway, NJ (onsite - physical presence required)

Reports To: Sr. Director of IT

Rate: $65-$75/hour, not overtime eligible 

Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future


Position Summary


We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.


Essential Duties & Responsibilities

  • Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
  • Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
  • Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
  • Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
  • Support audits, inspections, CAPA investigations, and deviations related to computerized systems
  • Collaborating with senior validation leads and SMEs to drive consistent practices across sites

Requirements

Position Requirements and Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Experience:  

  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Specialized Knowledge and Skills: 

  • Familiarity with GAMP 5 principles and risk-based validation
  • Exposure to Caliber LIMS
  • Exposure to SAP (QM, MM, PP) in a GxP context
  • Experience with BMRAM or equivalent CMMS/calibration systems
  • Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

Work Environment & Physical Demands:

  • This is an on-site position
  • Must be able to work extended hours or weekend hours, as may be required.

Noise:

  • No extraordinary noise levels.

Standing/Lifting:

  • Very unlikely, but can be able to lift at least 20 lbs.

Visual:

  • No extraordinary requirements.

Stress:

  • High-paced demanding environment to meet ambitious project goals.

Travel:

  • Moderate domestic travel may be required.