VALIDATION ENGINEER IV

The Validation Engineer IV performs well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities.

Requirements

• Author validation plans
• Oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements
• Review and approve commissioning, qualification and validation related system lifecycle documentation
• Provide direction on equipment/process change control development
• Work closely with other validation department personnel and cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management
• Perform a periodic review of systems to monitor the validation status of the system
• Help define validation strategies based on regulations, guidance documents, industry practice and experience
• Assist management with mentoring and training of colleagues on policies and procedures
• Team representative on validation projects leading by example on significant projects requiring complex technical solutions
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance
• Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
• Coordinate and execute validation protocol activities with consistent and effective communication with affected departments
• Write protocols and technical study approaches
• Review document changes for validation impact
• Review deviation reports for validation impact
• Review and approval of change controls
• Propose corrective actions to validation manager and appropriate departments and implement the required changes

Benefits

• Competitive salary
• Comprehensive benefits package
• 401(k) matching
• Health and wellness programs
• Flexible work arrangements
• Professional development opportunities
• Diverse and inclusive work environment
• Compliance with safety and health regulations
• Collaborative and supportive work environment