Senior Lab Instruments Software Validation Analyst​/Technical Writers

Job Description:

We are seeking an experienced Lab Instruments Software Validation Analyst with 10 years of proven expertise in the clinical research industry, including a minimum of 5 years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials.

The ideal candidate will have in-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (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.

• Validation Planning & Execution: Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software.
• Design and implement testing strategies: Design and implement integration, regression, and performance testing strategies.
• Compliance management: Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards.

• Documentation: Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications.
• Regulatory compliance: Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies.
• System reviews: Conduct periodic system reviews and manage revalidation activities.

• Risk assessments: Perform in-depth risk assessments and gap analyses to mitigate compliance risks.
• CAPA leadership: Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented.

• Cross-functional collaboration: Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes.
• Technical cooperation: Partner with software/hardware development teams for issue resolution and debugging.
• Mentorship: Mentor and train junior analysts, foster knowledge sharing and best practices.

• 10 years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry.
• 5 years of hands-on expertise in the following skill areas:
• Analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems).
• 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.
• Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessment Documents, Traceability Matrices, Validation Summary Reports).
• Process improvement and SOP/work practice development in validation life cycle management.
• Strong leadership skills with the ability to manage multiple validation projects simultaneously.
• Excellent communication, technical writing, and collaboration skills across global teams.

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