Description

As a Principal Process Validation Engineer, you will lead validation efforts for strategic projects, develop comprehensive validation plans, and ensure compliance with industry standards. This role involves collaborating across departments, training personnel, and maintaining high safety and quality standards while driving continuous improvement initiatives.

Requirements

• •Bachelor's degree or equivalent experience
• •Minimum 8 years of validation engineer experience
• •In-depth knowledge of ISO 13485, EU GMP, CFR Part 820
• •Excellent understanding of plastic process manufacturing
• •Experience dealing with customers
• •Excellent written and verbal communication skills
• •Ability to lead, influence, and train others
• •Ability to work in a fast-paced environment
• •Ability to travel as required
• •Organizational and prioritization skills
• •Ability to collaborate across functional teams
• •Ability to work independently on projects
• •Compliance with safety and quality policies
• •Ability to use standard office equipment
• •Effective communication and decision-making skills
• •Ability to read and interpret data
• •Ability to work well with others
• •Ability to multi-task and problem solve
• •Ability to make independent judgments
• •Ability to analyze and solve problems

Tasks

• •Lead validation efforts for all strategic projects on site
• •Prepare, review, and approve the Site Validation Master Plan
• •Develop Validation Plans to support the Site Validation Master Plan
• •Serve as the subject matter expert on Cleaning Validation, Process Validation, Equipment Validation, Computer System Validation, Data Integrity, and Facility Qualification
• •Prepare, review, and approve qualification and validation documentation for instruments, equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning processes
• •Review and approve third-party generated protocols and reports
• •Encourage shared learning across the organization regarding system and technology best practices
• •Chair, schedule, and minute validation meetings
• •Prepare, review, and approve standard operating procedures and policies
• •Perform periodic reviews of systems to maintain validation status
• •Support the setup and maintenance of electronic validation documentation
• •Ensure proper archiving and filing of hard copy validation documentation
• •Develop and implement site validation strategy to meet customer and company needs
• •Collaborate with all departments to ensure new processes meet requirements
• •Represent the company at customer meetings to address business needs
• •Assist in training and developing personnel on new processes or systems
• •Ensure procedures and systems facilitate the introduction of new processes and equipment
• •Lead and manage a high-performing team to achieve business goals
• •Make decisions to stop work in the plant to prevent material damage or employee jeopardy
• •Approve entrance of third parties into the plant as per company procedures
• •Support Lean Sigma programs and activities to meet set targets
• •Comply with the company’s safety and quality policies at all times

Benefits