Validation Engineer II

Описание вакансии

Key Responsibilities

• Contribute to validation projects by developing schedules, master plans, impact assessments, risk assessments, validation protocols, reports, and requirements trace matrices for complex systems supporting clinical and commercial manufacturing.
• Perform Computer System Validation (CSV) elements for equipment, utility systems, facilities, processes, and automation systems.
• Author validation master plans, risk assessment documents, protocols, technical reports, and requirement trace matrices.
• Embed data integrity principles into daily operations and validation programs.
• Coordinate validation activities with cross-functional teams to ensure timely and budget-conscious execution.
• Foster collaborative relationships across teams to deliver high-performance validation programs.
• Identify and drive continuous improvement initiatives for compliant and lean sustainable solutions.
• Review project-related documents and data from vendors, validation teams, and project teams.
• Represent the validation department on cross-functional project teams.

Basic Qualifications

• Bachelor’s degree in science or a related field with 4+ years of relevant experience, OR
• Master’s degree (MS or MBA) with 2+ years of relevant experience.
• Understanding and application of validation principles, including GAMP, Part 11, Data Integrity, and Annex 11.
• Proficiency in current Good Manufacturing Practices (GMPs).
• Working knowledge of equipment, systems, and industry practices.
• Strong verbal, technical writing, and interpersonal communication skills.
• Ability to resolve moderately complex validation issues with limited supervision.
• Proficiency in Microsoft Office applications.

Preferred Qualifications

• Experience using Root Cause Analysis tools.
• Operational excellence mindset and experience driving continuous improvement initiatives.
• Experience coordinating cross-functional validation projects.