Engineer , Continuous Improvement

Position: Engineer I, Continuous Improvement

Location: Danbury, CT

Job : 1112703

# of Openings: 1

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.

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

The Continuous Improvement Engineer plays a vital role in supporting the engineering and technical operations at Mannkind's Danbury site. This position focuses on driving continuous improvement projects across multiple business areas, optimizing equipment, utilities, and facility systems to enhance reliability and efficiency. In addition to hands-on engineering work, the role includes technical writing responsibilities such as updating procedures and drafting change controls.

The engineer will be instrumental in planning and executing capital and maintenance projects, ensuring compliance with regulatory standards and contributing to a culture of operational excellence. The ideal candidate combines strong project management abilities with a solid engineering foundation in a cGMP-regulated pharmaceutical or biotech environment, directly supporting Mannkind's commitment to delivering exceptional quality and innovation.

• Lead and actively participate in capital improvement initiatives, equipment installations, utility upgrades, and infrastructure projects from initial concept through successful completion.
• Ensure all engineering activities consistently meet cGMP standards, as well as safety and environmental regulations.
• Provide hands-on technical support to manufacturing, maintenance, and quality teams, assisting with troubleshooting and resolving equipment or process challenges.
• Develop comprehensive project plans, budgets, and timelines; oversee vendors and contractors to ensure project objectives are met.
• Prepare and maintain engineering documentation, including design specifications, technical drawings, change controls, and commissioning/qualification protocols.
• Support the upkeep of equipment lifecycle records and plant layout documentation.
• Identify opportunities to enhance equipment performance, energy efficiency, and process safety, and implement effective solutions.
• Collaborate closely with cross-functional teams—Quality Assurance, Manufacturing, Facilities, and Validation—to ensure operational readiness and project success.
• Take on additional assignments as needed to support the continuous improvement and reliability of site operations.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

• BA/BS in a technical discipline with 1-3 years of experience in a regulated pharmaceutical environment
• Minimum BS degree in Chemical, Mechanical, or Electrical Engineering
• Experience with cGMP quality system and processes
• Strong technical writing skills
• Working knowledge of various production equipment such as filling, packaging, and reactor vessels.
• Experience with building systems and equipment including electrical, compressed air, water, HVAC, and waste systems
• Experience managing small and medium size installation and upgrade projects from inception to completion
• Demonstrated excellent written and oral communication skills
• Strong interpersonal skills
• Ability to work a rotating on-call schedule to support production as needed

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

Pay Range: $57,600 - $86,400 per year

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