Engineer II, Validation

Role Summary

The Engineer II, Validation understands validation methodology and can apply it to process, packaging, equipment, and cleaning activities. Generates and executes validation protocols with limited supervision. Adheres to validation schedules.

Responsibilities

• Implements the Process and Cleaning Validation Program protocols and helps maintain the Equipment Validation Lifecycle process.
• Monitors reoccurring validation activities to meet schedule and production timelines.
• Writes validation protocols and reports with limited supervision.
• Writes Equipment standard operating procedures.
• Generates URSs, IOQ, PQ, and PPQ documentation with limited supervision.
• Participates in risk assessments for product and process definition.
• Adheres to and maintains compliance with corporate polices and values throughout Manufacturing Technical Services.
• Adheres to and promotes MannKind Vision and Values, Code of Business Conduct and Ethics.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Qualifications

• BA/BS in a technical discipline with 2-4 years of experience or MS with 1-3 years related experience or an equivalent combination of training and related experience
• Knowledge in risk assessment tools
• Knowledge of bulk powder manufacturing and filling, packaging technology, and kitting desirable.
• Excellent written and verbal skills with the ability to communicate clearly, concisely, and effectively.

Skills

• Technical communication
• Validation protocol development
• Documentation management
• Process and equipment validation

Education

• BA/BS or MS in a technical discipline (as specified under Qualifications)

Additional Requirements

• Regulatory environment knowledge (FDA, ISO 13485, European requirements, etc.)