Computer System Validation Specialist - Pharmaceutical Manufacturing

Position Overview
We are seeking an experienced Computer System Validation (CSV) Specialist to lead commissioning and validation activities for automated laboratory systems in our pharmaceutical manufacturing facility. 

 Essential Qualifications

Education
- Bachelor's degree or higher in Computer Science, Information Systems, Engineering, or related discipline

 Experience Requirements
- **Minimum 5+ years** of hands-on experience in pharmaceutical environment
- Proven track record with computerized/automated system qualification processes
- Direct experience with system commissioning and validation lifecycle

Technical Expertise Required
- Data Systems: Proficiency with computerized systems utilizing data collection software and databases
- Laboratory Systems: Working knowledge of laboratory equipment and instrumentation (preferred)
- Network Protocols: Understanding of network communications protocols (TCP/IP, etc.)
- Regulatory Compliance: Strong working knowledge of:
- cGMP (current Good Manufacturing Practices)
- FDA regulations
- 21 CFR Part 11 (Electronic Records/Electronic Signatures)
- Data Integrity requirements (ALCOA+ principles)

Professional Skills
- Excellent technical writing abilities in English
- Proficiency with Microsoft Office suite (Word, Excel, PowerPoint, Visio)
- **Bilingual: English and Spanish (Required)**

 Key Responsibilities
- Lead commissioning and validation activities for computerized laboratory systems
- Develop and execute qualification protocols (IQ/OQ/PQ)
- Author technical validation documentation in compliance with regulatory standards
- Ensure systems meet cGMP, 21 CFR Part 11, and data integrity requirements
- Collaborate with cross-functional teams and stakeholders
- Support regulatory inspections and audits