Quality Validation Engineer

Job Description

Essential Duties and Responsibilities:

• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems
• Schedules, plans, manages and executes studies for cleaning validations
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocols
• Reviews and approves validation project documentation
• Coordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project executions
• Leads and coordinates cross-functional teams for project validation
• Priorities, manages and executes multiple projects utilizing the project management methodologies
• Oversees external validation resources
• Supports the development of best and proven validation practices in the validation department based on current industry guidelines and practices
• Authors relevant standard operating procedures for ensuring compliance with the company’s policies
• Supports regulatory submissions and also regulatory agency inspections whenever requested
• Champions continuous improvements in the validation department

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• cGMP and Regulatory Compliance - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organization
• Professional Communication - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Computer Literacy - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
• Collaboration - Utilize teamwork and problem solving skills across all departments and internally to Quality Assurance
• Project Management - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manner

Education / Experience

• Bachelor’s degree or higher in relevant scientific/technical field
• Total Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferred
• Experience in project management
• Must be well organized with a keen attention to detail
• Knowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time