Senior CSV Engineer – Analytical Systems & Software Validation

Key Responsibilities

• Lead and execute lifecycle validation (GxP) for laboratory analytical equipment and integrated software systems (e.g., Chromatography Data Systems, LIMS, spectrophotometers, qPCR software).
• Draft, review, and execute lifecycle documentation including Validation Plans, User Requirement Specifications (URS), Risk Assessments (FMEA), Functional Specifications, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Ensure all standalone and networked analytical systems strictly comply with FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ Data Integrity principles.
• Serve as the subject matter expert (SME) for computerized analytical software during internal audits and regulatory inspections.
• Collaborate with laboratory equipment vendors to review technical specifications, software patches, and factory/site acceptance testing (FAT/SAT) documentation.
• Investigate validation deviations, author comprehensive non-conformance reports, and implement robust Corrective and Preventive Actions (CAPAs).

Required Qualifications & Experience

• Education: Bachelor's degree in Life Sciences, Bioengineering, Computer Science, or a related technical field.
• Experience: Minimum of 5-8 years of direct Computer Systems Validation (CSV) experience within the pharmaceutical or biotech industry.
• Technical Expertise: Proven track record validating analytical equipment software (e.g., Empower, LabVantage, SoftMax Pro, or instrument-specific control software).
• Regulations: Deep knowledge of GAMP5, FDA 21 CFR Part 11, Annex 11, and current Data Integrity guidance.

Preferred Qualifications

• Cell & Gene Therapy (CGT): Direct validation experience within a Cell or Gene therapy manufacturing facility or specialized ATMP QC laboratory.
• Agile Environments: Experience handling rapid-turnaround validation cycles typical for personalized medicine workflows.