Description

Lead GxP IT and computer systems implementations within a biotech or pharmaceutical environment.

Responsibilities

• Lead GxP computer system implementations by collaborating with Business Process Owners, vendors, and QA Validation.
• Execute CSV activities, including creating and executing IQ/OQ/PQ test scripts and SDLC deliverables.
• Own data integrity strategies, covering data protection, backups, disaster recovery, and decommissioning or archiving plans.
• Manage systems under change control, performing impact assessments and maintaining necessary documentation.
• Serve as the site lead for data integrity, compliance, and inspection readiness for GxP computer systems platforms.

Required Skills

• 5+ years of technical experience in systems engineering or IT support.
• 4+ years of experience within the biotech or pharmaceutical industry.
• Proficiency with Windows Server and Active Directory.
• Hands-on experience with SQL and OS Patching.
• Experience with SDLC, including User Requirements Specifications and Risk Assessments.
• Knowledge of eQMS and GxP Computer System Standard Operating Procedures (SOPs).
• Experience performing periodic reviews of user accounts, backups, and audit trails.
• Ability to troubleshoot GxP instrument software and PC-based technical issues.

Preferred Skills

• Experience representing IT during Global Quality Audits or third-party inspections.

Key Skills

Education

Any Graduate