Engineer III

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Job Summary:

The Electromechanical Engineer supports manufacturing from solution prep through to drug packaging by taking the role in the design, development, implementation, and sustainment of processes throughout the commercial manufacturing process. This role will work with the production engineering team, and directly interact with production, automation and controls, and maintenance teams to build capacity and repeatability within the manufacturing processes during concurrent operations and future scale up initiatives.

Essential duties and key job responsibilities and essential functions.

Design and develop electromechanical system upgrades, ensuring functionality, reliability, and cost-effectiveness
Conduct feasibility studies to evaluate the potential of new designs/modification
Collaborate with cross-functional teams, to troubleshoot electrical and mechanical components
Perform simulations, prototypes, and testing to validate designs and identify areas for improvement
Create technical documentation, including specifications, drawings, and test plans
Supports the Manufacturing of clinical and commercial products through oversight, process improvement, and troubleshooting of the process and equipment. To include working directly with Automation and Maintenance personnel.
Calculate appropriate sizing of process components, including pumps, fans, heaters, heat exchangers, etc.
Develop, review and refine process documentation, and process monitoring and measurement documentation to ensure process parameters are consistently maintained.
Lead equipment modifications, process validation and training of personnel
Adheres to and promotes MannKind 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 as necessary.

Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to

perform essential duties; physical requirements for job if any

.

BA/BS 4-5 years experience in an electrical discipline (mechanical knowledge preferred) or MBA with 24 years experience in a regulated pharmaceutical environment. Preferred experience performing electro-mechanical design, implementation, and sustainment in a regulated industry.
Knowledge of electrical schematics and use of CAD software
Demonstrated knowledge of cGMPs
Demonstrated experience in supporting production and manufacturing
Demonstrated knowledge in risk assessment tools and approaches
Demonstrated knowledge of six-sigma and lean manufacturing
Practical knowledge of Automation systems
Ability to troubleshoot both mechanical and electrical issues
Excellent written and verbal skills with the ability to communicate clearly, concise and effectively
Strong knowledge and demonstrated use of statistics; strong analytical skills and the ability to rapidly analyze information
Ability to adapt and work in a high paced environment

(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)

#J-18808-Ljbffr