Engineer I, Continuous Improvement

Role Summary

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.

Responsibilities

• 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‚ÄîQuality Assurance, Manufacturing, Facilities, and Validation‚Äîto ensure operational readiness and project success.
• Take on additional assignments as needed to support the continuous improvement and reliability of site operations.

Qualifications

• 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

Additional Requirements

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