What are the responsibilities and job description for the Lab Instruments Software Validation Analyst / Technical Writer position at Katalyst Healthcares & Life Sciences?
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.
- Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline required.
- Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance preferred.
- 06 - 09 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environment.
- 03 - 05 years of specialized experience in the following areas: -
- Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analysers, 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.
- We are seeking a Lab Instruments Software Validation Analyst with 06 - 09 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry.
- The successful candidate will be responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials.
- This role requires a strong technical background in validation methodologies, regulatory compliance, and equipment qualification, along with the ability to collaborate effectively with cross-functional teams.
- The candidate should bring at least 03 - 05 years of focused, hands-on expertise in specialized validation skill areas.
