Manager, Validation

Duties & Responsibilities

• Manages personnel, budgets and projects relating to systems, process, cleaning and equipment validation in GXP relevant areas such as Operations, R&D, Marketing at the facility.
• Maintains comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant equipment, systems and processes.
• Identifies current trends in regulatory compliance for all validation procedures for equipment, systems and processes.
• Implements and updates the validation master plan (VMP) to assure compliance with regulatory and corporate requirements.
• Supports Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future IQ/OQ/PQ scans be performed on equipment sourced.

Requirements

• Bachelor degree from an accredited institution in a scientific, bioengineering, or relevant discipline required, and a minimum of ten (10) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
• In lieu of a degree, a minimum of fifteen (15) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
• Experience must be inclusive of at least three (3) years in a leadership role leading people and/or projects.

Desired Skills, Experience And Abilities

• Shares technical and compliance knowledge horizontally and vertically across the site.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross-functional teams.
• Strong knowledge of statistics, data bases, and quality principles.
• Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
• Must be self-motivated and of high integrity.