Engineer I, Continuous Improvement
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Job Location:
Danbury, CT - USA
Yearly Salary:
USD 1 - 3
Posted on:
02-11-2025
Vacancies:
1 Vacancy
Job Summary
MannKind Corporationfocuses 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 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 MannKind 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 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 Continuous Improvement Engineer plays a vital role in supporting the engineering and technical operations at Mannkinds Danbury site. This position focuses on driving continuous improvement projects across multiple business areas optimizing equipment utilities and facility systems to enhance reliability and 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 Mannkinds commitment to delivering exceptional quality and innovation.
At MannKind 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 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 Continuous Improvement Engineer plays a vital role in supporting the engineering and technical operations at Mannkinds Danbury site. This position focuses on driving continuous improvement projects across multiple business areas optimizing equipment utilities and facility systems to enhance reliability and 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 Mannkinds commitment to delivering exceptional quality and innovation.
Responsibilities and Duties:
- 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 teamsQuality Assurance Manufacturing Facilities and Validationto 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.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
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA ISO 13485 European requirements etc.)
Key Skills
- Anti Money Laundering
- English Speaking
- Data Entry
- Food
- Investigation
- Adobe Indesign
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
