Job Description
SR. COMPUTER SYSTEMS VALIDATION ENGINEER
Biotech Industry. El Segundo, CA
Direct Hire
We are looking for a Sr. Validation Specialist with 21 CFR Part 11 GxP validation experience to validate and qualify new system implementations, upgrades, and maintenance.
The right person will be able to provide guidance and risk assessments, as well as develop and review documentation, policies, and operating procedures. He or she will also investigate deviations and CAPAs, work closely with QA, and ensure GLP/GMP compliance.
REQUIREMENTS
BS in Computer Science, Engineering, Science, or similar and 5+ years of directly related experience.
Demonstrated 21 CFR 11 experience, as well as electronic submission and signature guidelines and practices
Proven experience with software/system implementation and solid SDLC knowledge, particularly with enterprise-level systems (ERP, QMS, LIMS, CRM, MFG, etc)
Excellent documentation and communication experience
BENEFITS
Direct-hire role with excellent salary and benefits.