JOB DESCRIPTION:

We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems, analytical instruments, and enterprise software. This includes supporting system implementation, upgrades, administration, and retirement, while ensuring compliance with regulations and internal procedures. The role works closely with Manufacturing, Quality, Engineering, and IT teams.

Responsibilities:

• Lead validation efforts for new and existing systems.
• Act as the Subject Matter Expert (SME) for CSV, analytical, and enterprise systems.
• Review and approve qualification documents (IQ/OQ/PQ).
• Prepare user requirements and system configuration documents.
• Support data integrity assessments and audit trail reviews.
• Oversee equipment procurement and ensure proper installation and qualification.
• Perform system administration tasks (user setup, backups, troubleshooting).
• Write and update SOPs for system use and maintenance.
• Participate in risk assessments and change controls.
• compliance with 21 CFR Part 11, GAMP 5, and other regulatory guidelines.

Requirements:

• Bachelor’s degree in science or engineering field.
• 5–10 years of work in validation, preferably in a pharma or biotech environment.
• Good understanding of CSV, data integrity, and GMP regulations.
• Experience with lab instruments and enterprise systems (like LIMS, CDS, ERP).
• Strong documentation and technical writing skills.
• Ability to troubleshoot and solve system-related issues.
• Comfortable working with different departments and vendors.

• Lead validation efforts for new and existing systems.
• Act as the Subject Matter Expert (SME) for CSV, analytical, and enterprise systems.
• Review and approve qualification documents (IQ/OQ/PQ).
• Prepare user requirements and system configuration documents.
• Support data integrity assessments and audit trail reviews.
• Oversee equipment procurement and ensure proper installation and qualification.
• Perform system administration tasks (user setup, backups, troubleshooting).
• Write and update SOPs for system use and maintenance.
• Participate in risk assessments and change controls.
• compliance with 21 CFR Part 11, GAMP 5, and other regulatory guidelines