Manufacturing Engineer

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

ROLE SUMMARY

The Manufacturing Process Engineer plays a crucial role in ensuring consistent high performance of manufacturing equipment and processes. This “hands on” position owns the manufacturing process and focuses on the performance of manufacturing operations to ensure quality, improve performance and reduce line scrap / waste.

Responsibilities include performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a Pharmaceutical, Combination Product, Medical Device cGMP environment. These activities include collaboratively identifying/implementing process improvements on existing product lines and new product introductions. The ideal candidate will be able to assist in troubleshooting, equipment/facility design, and cost improvement projects. The incumbent will provide process ownership, technical expertise and support all production activities as needed. Additional responsibilities include ownership of pFMEAs, Project Management, application of Six Sigma methods, and coordination of training. The individual will provide primary product support for key customer product(s) and/or new product introduction (NPI) programs. Areas of responsibility will include the Inspection and Packaging operations at the Maryland Heights facility.

ROLE RESPONSIBILITIES

• Serve as the technical lead and owner of assigned manufacturing equipment and process systems.
• Lead improvements for vision systems, including deep learning (AI) applications, to enhance quality and efficiency. Develop and apply AI-related expertise as required, with an expectation of ongoing skill progression.
• Lead projects and participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes.
• Investigate process deviations on the manufacturing floor using structured Six Sigma-based methods.
• Collaborate with Operations, Quality Assurance (QA), Operational Excellence (OPEX), Maintenance and other internal experts to develop quality investigations, determine root causes, and implement corrective and preventive actions (CAPA).
• Develop and execute manufacturing protocols and machine trials as needed to support Compliance and Continuous Improvement projects.
• Facilitate Operations equipment and process ownership by being the primary internal technical training resource for Operations Management and production floor teams.
• Provide support to manufacturing staff on the production floor to ensure smooth scale-ups and technical transfers.
• Develop, create, and qualify samples for use in validation, equipment challenges, and experimental studies to assess system performance.
• Identify and implement cost-saving initiatives, with a specific focus on quality and efficiency improvements.
• Lead technical improvement projects aimed at achieving "zero defects," enhancing equipment reliability, and maximizing utilization.

QUALIFICATIONS

Education:

• Bachelor’s degree (or higher) in Process Engineering, Industrial Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a Science-related field.

• Completion of a recognized certificate program or specialized courses in process engineering, demonstrating comprehensive knowledge and practical skills in process design, optimization, control systems, safety considerations, and project management.

• Knowledge of electro-mechanical principles and automated machine and visual process control.

• Ability to present technical information clearly and communicate effectively at all levels of the organization.

• Demonstrated ability to contribute to and lead project teams.

• Strong analytical skills, capable of simplifying strategy into actionable steps with clear accountability, making decisions efficiently and accurately based on the best available information, and communicating priorities concisely.

Experience:

· 2 or more years of experience in Pharmaceutical or Combination Product/Medical Device Manufacturing

· Experience leading engineering improvement projects

· Familiarity with Fault Tree Analysis.

· Experience with risk management files and maintenance of pFMEAs

· Understanding of Design Control regulations

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