Engineer II, Validation

Mann Kind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension.

Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

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.

• Executes protocols to validate systems.
• Implements the Process and Cleaning Validation Program protocols and helps maintain the Equipment Validation Lifecycle process.
• Monitors recurring 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 Mann Kind Vision and Values, Code of Business Conduct and Ethics.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments.

• 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.

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Note:

Regulatory environment requirements and/or compliance include all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)

With the spread of the coronavirus, many individuals are concerned about access to their medication supply. At this time, Mann Kind does not anticipate that the supply of its inhalable insulin Afrezza (insulin human) Inhalation Powder will be affected by the coronavirus.

We will continue to closely monitor our supply chain for potential impact to the supply of Afrezza. Mann Kind sources critical raw materials from suppliers in the United States and Europe and we remain in close communication with key suppliers to assure a reliable supply of insulin.

Our US manufacturing facility is fully operational and we are taking a number of steps to prevent any impact to our supplies. Afrezza is still readily available in U.S. pharmacies, and if needed, pharmacies can order additional supplies from wholesalers with expected delivery within 1-2 days. As the global situation evolves, we will continue to take the necessary steps to safeguard the reliable supply of Afrezza.