Description

You will own the execution and oversight of validation activities within a GMP environment.

Responsibilities

• Execute routine qualification for equipment, facilities, utilities, and computer systems in biopharmaceutical production.
• Conduct room qualification and smoke studies in Grade A pharmaceutical facilities.
• Oversee and support media fill qualifications.
• Perform requalification and periodic review of critical assets like autoclaves, cold rooms, and freezers.
• Support departmental selection, review, and upgrade processes for production systems.

Required Skills

• 6+ years of GMP validation or similar experience in GMP manufacturing.
• 10+ years of GMP validation experience in a regulated manufacturing environment (in lieu of degree).
• Minimum 3 years leading validation projects.
• Expertise in Ellab data logger usage and software.
• Comprehensive understanding of cleaning validation principles.
• Familiarity with pharma-grade utilities (HVAC, water, gases).
• Excellent comprehension of FDA/EU/USDA regulatory requirements for biological articles.
• Proficiency in technical writing, including independent protocol execution and report generation.
• Ability to analyze production data to assess GMP compliance and troubleshoot issues.

Key Skills

Education

Bachelor's degree