Software Validation Analyst / Tech Writer

Position : Lab Instruments Software Validation Analyst / Tech Writer

Location: Highland Heights, KY

Visa: H1B

Duration: 4+ month project

Contract

Required Skills & Experience 6 9 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environment. 3 5 years of specialized experience in the following areas:

• Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analyzers, PCR systems, sequencers).
• Equipment qualification (DQ, IQ, OQ, PQ).
• Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
• Validation documentation authoring (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 deliver on multiple projects concurrently.

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 execution in GxP-regulated facilities.
• Documentation & Compliance
• Prepare and maintain validation life cycle 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 processes for laboratory systems.
• Risk Management & CAPA
• Conduct risk assessments and gap analyses to identify potential issues.
• Assist in deviation investigations and support Corrective and Preventive Actions (CAPA) implementation.
• Collaboration & Continuous Improvement
• 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 activities.
• Recommend process improvements and contribute to updates of SOPs and validation practices.