Manufacturing Engineer II jobs in United States
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Kindeva Drug Delivery · 7 hours ago

Manufacturing Engineer II

Kindeva Drug Delivery is dedicated to creating life-saving nasal spray medications, and they are seeking a Manufacturing Engineer II to optimize equipment performance and drive continuous improvement across their pharmaceutical production lines. This role involves troubleshooting equipment issues, leading lean manufacturing initiatives, and supporting new equipment design to ensure compliance and efficiency in operations.

Manufacturing
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H1B Sponsor Likelynote

Responsibilities

Monitor and optimize manufacturing equipment performance in alignment with cGMP standards
Troubleshoot and resolve complex equipment issues to minimize production downtime
Lead lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality
Identify and implement procedural or automation improvements for continuous optimization
Support new product and equipment design reviews, process development, and staff training
Serve as a technical point of contact for clients and contract manufacturing services
Develop and maintain systems to visualize and analyze key performance indicators (KPIs)
Support equipment-related deviations, CAPAs, and Change Controls as the equipment SME
Assist with Installation, Operational, and Performance Qualification (IOPQ) activities
Ensure equipment and processes meet regulatory requirements and are fit for commercial use. Oversee labeling, artwork changes, and packaging configurations as needed

Qualification

Lean manufacturingSix SigmaGMP knowledgeAutoCADAnalytical skillsCommunication skillsInterpersonal skillsProblem-solving skillsProject management

Required

Bachelor's degree in Engineering or related field and/or equivalent experience
2+ years of relevant experience in manufacturing with a focus on equipment and process improvement
Proficiency in CAD software, primarily AutoCAD to design and update comprehensive factory and work cell layouts
Create, maintain, and update detailed technical documents, including assembly instructions, work instructions (WIs), and standard operating procedures (SOPs)
Proven track record of successfully implementing improvement initiatives in a manufacturing environment
Strong analytical and problem-solving skills with the ability to use data to drive decision-making
Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments
Ability to manage multiple projects and priorities in a fast-paced environment

Preferred

Experience with automation, nasal, or related drug delivery device manufacture and packaging
Knowledge of GMP (Good Manufacturing Practices) and regulatory requirements in the pharmaceutical industry
Lean manufacturing or six sigma certifications
Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc

Company

Kindeva Drug Delivery

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Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.

H1B Sponsorship

Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)

Funding

Current Stage
Late Stage
Total Funding
$46.96M
Key Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M

Leadership Team

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Brian Schubmehl
Chief Human Resources Officer
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Company data provided by crunchbase