Lab Instruments Software Validation Analyst / Technical Writers

Lab Instruments Software Validation Analyst / Technical Writers

Kentucky, Highland Heights

09/25/2025

Contract

Active

Job Description:

Job Summary

We are seeking a Lab Instruments Software Validation Analyst with 69 years of experience in the clinical research, pharmaceutical, or biotechnology industry.

This role is responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials.

The ideal candidate will possess strong validation expertise, technical writing skills, and the ability to collaborate across cross-functional teams.

Key Responsibilities

Validation Planning & Execution

• Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ) for laboratory instruments and computerized systems.
• Support integration, regression, and performance testing of software and equipment.
• Participate in validation activities within GxP-regulated environments.

Documentation & Compliance

• Prepare and maintain validation lifecycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, and GAMP 5 guidelines.
• Contribute to periodic reviews and revalidation of laboratory systems.
• Conduct risk assessments and gap analyses to identify potential issues.
• Assist in deviation investigations and support implementation of Corrective and Preventive Actions (CAPA).
• Work closely with Quality Assurance, R&D, Production, and IT teams to deliver validation deliverables.
• Collaborate with hardware/software development teams on troubleshooting and debugging.
• Recommend process improvements and contribute to updates of SOPs and validation practices.

Required Qualifications

• Bachelors degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or a related discipline.
• Masters degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance are preferred.
• 69 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environments.
• 35 years of specialized expertise in:
• Validation of analytical instrument systems (e.g., spectroscopy, chromatography, PCR systems, sequencers).
• Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
• Authoring validation documentation (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrix, Validation Reports).
• Risk management and CAPA support for validated systems.
• Strong technical writing, analytical, and communication skills.
• Ability to work in global, cross-functional team environments and manage multiple projects concurrently.

Preferred Qualifications

• Experience with software validation in regulated laboratory environments.
• Familiarity with instrument integration and computerized system validation strategies.

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