Senior Lab Instruments Software Validation Analyst​/Technical Writers

Position: Senior Lab Instruments Software Validation Analyst / Technical Writers
Location: Highland Heights

Senior Lab Instruments Software Validation Analyst / Technical Writers

Kentucky, Highland Heights

09/25/2025

Contract

Active

Job Description:

Job Summary We are seeking a highly experienced Senior Lab Instruments Software Validation Analyst with over 10 years of expertise in the clinical research industry.

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

The ideal candidate will possess deep knowledge of GCP, GLP, cGMP, and regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11, along with strong leadership and cross-functional collaboration skills.

Key Responsibilities Validation Planning & Execution

• Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software systems.
• Design and implement integration, regression, and performance testing strategies.
• Oversee validation execution in GxP-regulated facilities, ensuring compliance with SOPs and international standards.

Documentation & Compliance

• Author, review, and maintain validation lifecycle documentation including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications.
• Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal quality policies.
• Conduct periodic system reviews and manage revalidation activities.
• Perform in-depth risk assessments and gap analyses to mitigate compliance risks.
• Lead investigations into deviations and ensure effective implementation of Corrective and Preventive Actions (CAPA).
• Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes.
• Partner with software and hardware development teams for issue resolution and debugging.
• Mentor and train junior analysts, promoting knowledge sharing and best practices across teams.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or a related discipline.
• 10+ years of progressive experience in laboratory instrument and software validation within clinical research, pharmaceutical, or biotechnology industries.
• 5+ years of hands-on expertise in:
• Validation of analytical instrument systems (e.g., spectroscopy, chromatography, PCR systems, next-gen sequencers).
• Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation.
• Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
• Risk assessment, root cause analysis, and CAPA management.
• Authoring and reviewing validation documentation (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrices, Validation Summary Reports).
• Process improvement and SOP/work practice development in validation lifecycle management.
• Strong leadership skills with the ability to manage multiple validation projects simultaneously.
• Excellent communication, technical writing, and collaboration skills across global teams.

Preferred Qualifications

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

Certifications

• Preferred certifications:
  Computer System Validation (CSV), GAMP 5 Practitioner, or Quality/Regulatory Compliance credentials.

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