Overview
On Site
Full Time
Skills
Collaboration
Training
IQ
OQ
PQ
GDP
Regulatory Compliance
Software Testing
Auditing
Process Improvement
Documentation
Computer Science
Computerized System Validation
Pharmaceutics
Medical Devices
Software Development Methodology
Change Management
GAMP
GMP
ISO 9000
Project Management
Leadership
Quality Management
Document Management
Management
Job Details
Responsibilities:
- Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs).
- Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements.
- Provide leadership and training in validation activities.
- Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP).
- Ensure compliance with quality system elements for computer systems/software testing.
- Perform gap assessments and remediation activities.
- Investigate and resolve non-conformances, deviations, CAPAs, and change controls.
- Participate in internal/external software audits.
- Contribute to process improvements and documentation.
- Bachelor's/Master's in Computer Science/Engineering.
- 10+ years in CSV in regulated industries (pharma, biotech, medical device).
- Proficiency in SDLC, change management, validation techniques.
- Experience with GAMP 5, FDA 21 CFR Part 11, EU GMP, ISO standards.
- Project management and leadership experience.
- Familiar with Quality Management, Document Management, and Validation Management Systems.
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