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In Lims Validation Jobs in Washington (NOW HIRING)

Review datasets generated from method development, method validation, and sample analysis studies ... in LIMS. * Review laboratory equipment calibration records, logbooks, and other quality ...

Review datasets generated from method development, method validation, and sample analysis studies ... in LIMS. * Review laboratory equipment calibration records, logbooks, and other quality ...

... in a regulated environment KNOWLEDGE, SKILLS AND ABILITIES: • Knowledge of administrating a LIMS ... Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates. Equal ...

The SME works closely with engineering, manufacturing, quality, validation, and system integration ... Requirements · Bachelor''s or Master''s degree in Automation, Electrical, Controls, Chemical ...

The SME works closely with engineering, manufacturing, quality, validation, and system integration ... Requirements · Bachelor's or Master's degree in Automation, Electrical, Controls, Chemical ...

The SME works closely with engineering, manufacturing, quality, validation, and system integration ... Requirements Bachelor's or Master's degree in Automation, Electrical, Controls, Chemical, Process ...

Scientist

Gaithersburg, MD · On-site

$70K - $85K/yr

Perform analysis including method transfer, development, validation and sample testing in support ... Knowledge of Watson LIMS and cell culture techniques a plus. * Perform other duties as assigned ...

Scientist

Gaithersburg, MD · On-site

$70K - $85K/yr

Perform analysis including method transfer, development, validation and sample testing in support ... Knowledge of Watson LIMS and cell culture techniques a plus. * Perform other duties as assigned ...

Experience in method development and validation of large molecules for cell and gene therapy ... Experience with LIMS system and data acquisition software. Performance requirements General

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In Lims Validation information

What is the difference between In Lims Validation vs Laboratory Technician?

AspectIn Lims ValidationLaboratory Technician
CertificationsGMP, GLP, Validation certificationsTypically relevant certifications include Lab Technician or related training
Work EnvironmentQuality assurance, validation labs, regulated industriesLaboratories performing tests and experiments
Job FocusEnsuring LIMS systems meet regulatory standardsPerforming tests, recording data, maintaining lab equipment

In Lims Validation professionals focus on validating Laboratory Information Management Systems to ensure compliance with industry standards, while Laboratory Technicians perform routine testing and data collection. Both roles are essential in regulated labs but differ in scope and responsibilities.

How to validate a LIMS system?

Validating a LIMS (Laboratory Information Management System) involves developing a validation plan, performing installation and operational qualification, and documenting each phase to ensure the system meets user requirements and regulatory standards. It typically includes testing data integrity, system security, and functionality, often supported by validation protocols and traceability. Familiarity with regulatory guidelines such as 21 CFR Part 11 is essential for compliance.

What are popular job titles related to In Lims Validation jobs in Washington?

For In Lims Validation jobs in Washington, the most frequently searched job titles are:

What cities in Washington are hiring for In Lims Validation jobs?

Cities in Washington with the most In Lims Validation job openings:

Validation Engineer / Validation Specialist

Stark Pharma Solutions Inc

Rockville, MD • On-site

Contractor

Posted 21 days ago


Job description

Position: Validation Engineer / Validation Specialist
Location: Maryland
Duration: Long Term

Job Overview

We are seeking an experienced Validation Engineer / Validation Specialist to support equipment, utility, and process qualification activities within a GMP pharmaceutical/biotechnology manufacturing environment. The ideal candidate will prepare and execute IQ, OQ, PQ, and Requalification (RQ) protocols, generate validation reports, develop technical documentation, and ensure compliance with cGMP and Good Documentation Practices (GDP).

Key Responsibilities

  • Prepare, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for equipment and utilities.
  • Generate qualification reports, SOPs, specifications, methods, and other validation documentation.
  • Develop acceptance criteria based on industry standards, manufacturer recommendations, user requirements, and cGMP guidelines.
  • Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
  • Analyze validation data and verify compliance with acceptance criteria.
  • Investigate, document, and resolve deviations associated with qualification studies.
  • Support commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
  • Prepare technical reports, gap assessments, and risk assessments.
  • Provide technical support for troubleshooting manufacturing equipment and systems.
  • Perform technical reviews of qualification documents.
  • Support internal and external audit readiness activities.

Required Qualifications

  • Bachelor's degree in Engineering or a related scientific discipline with a minimum of 4 years of validation experience, or 8+ years of relevant validation experience in lieu of a degree.
  • Experience working in GMP pharmaceutical or biotechnology manufacturing environments.
  • Hands-on experience with Equipment Qualification (IQ/OQ/PQ/RQ) activities.
  • Knowledge of cGMP regulations and Good Documentation Practices (GDP).
  • Experience with aseptic manufacturing processes.
  • Familiarity with Kaye AVS or Veriteq thermal mapping systems.
  • Working knowledge of cleanrooms, sterilization equipment, HVAC, WFI, RO, CCA, computerized systems, and isolator technology.
  • Experience with Microsoft Office, EDMS, LIMS, and related documentation systems.
  • Strong technical writing, communication, organizational, and project management skills.
  • Ability to work independently and collaboratively in a cross-functional environment.
  • Knowledge of maintenance and calibration procedures is preferred.