Computer Software Validation Specialist
Skills
- Computer software validation (CSV) experience
- Deep knowledge of 21 CFR Part 11, Annex 11, cGMP and GAMP 5
- IQ/OQ/PQ test development and execution
- CTMS implementation experience
- Experience with LIMS, CDS and scientific systems (familiarity preferred)
- Strong technical writing and documentation skills
- Business analysis and requirements gathering
- UAT coordination and SDLC proficiency
- Proficiency with MS Office and MS Visio
- Data flow mapping and data architecture exposure
Responsibilities
- Author, review, and approve validation master plans, URS, functional specifications, traceability matrices, and validation summary reports
- Develop and execute IQ, OQ, and PQ test protocols and perform testing execution
- Perform risk and impact assessments to define validation scope for new systems, upgrades, and changes
- Manage change control, document deviations, and drive CAPAs to closure
- Act as subject matter expert during internal and external audits and inspections
- Collaborate with business users to capture requirements, solution designs, and process/data flows
- Coordinate developers, stakeholders, and vendors; lead UAT activities and unit/functional testing as needed
- Maintain issue logs and ensure prioritization and timely resolution of critical issues
- Contribute to data flow mapping, system interfaces, and architecture discussions for compliant designs
Education
- Bachelor’s degree in Computer Science, Information Technology, Engineering, Biology, or related field, or equivalent experience
Benefits
- Market-competitive base salary with annual incentive plan
- Robust health and retirement benefits
- Generous flexible paid time off and company-paid holidays
- Flexible working hours and fully remote options for many roles
- Career development, training, and recognition programs
- Supportive, award-winning company culture
Average salary estimate
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