Manufacturing Engineer VII

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 manufacturing equipment and process systems.

• Efficiently manage and coordinate manufacturing technical processes and functions at the site in support of technical projects.

• Lead projects or 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.

• Develops project plans for New Product programs, product improvements and customer driven changes.

· Represent manufacturing as an individual contributor on assigned project teams to ensure the successful completion of key initiatives.

• Facilitate Operations equipment and process ownership by being the primary internal technical training resource for Operations Management and production floor teams.

• Support and collaborate with Maintenance and other technical support departments within manufacturing areas of responsibility.

· Advocate for process change proposals/requests related to technical support operations.

• Provide support to manufacturing staff on the production floor to ensure smooth scale-ups and technical transfers.

• Proactively anticipate potential problems, risks, and technical conflicts, and develop necessary contingency plans to optimize business continuity.

• Identify and implement cost-saving initiatives, with a specific focus on quality and efficiency improvements.

• Uphold product and company reputation by complying with government regulations.

• Lead technical improvement projects aimed at achieving "zero defects," enhancing equipment reliability, and maximizing utilization.

• Ensure work activities are conducted in strict accordance with safety guidelines and processing standards, including FDA's current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).

• Update and maintain Process Failure Mode Effects Analysis (pFMEAs).

• Provide technical/process support to operations personnel to ensure business continuity of serialized products.

· Other duties as assigned

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:

· Minimum of 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

Technical Skills:

• Ability to apply solid reasoning skills to investigations and project planning.

• Self-motivated and adaptable, with a willingness to learn and adapt to changing responsibilities and priorities.

• Demonstrated commitment to values-based leadership and achieving objectives in alignment with Kindeva Drug Delivery’s values and behaviors.

• Effective interaction with individuals at all levels of the organization.

• Strong oral and written communication skills.

• Flexibility to respond to constantly changing conditions and priorities.

• Preferably trained in Six Sigma methodologies and experienced in project management.

• Strong commitment to product quality, continuous improvement, and a working knowledge of Right First Time (RFT) principles.

PHYSICAL/MENTAL REQUIREMENTS

Job tasks may involve bending, twisting, and lifting items up to 35 lbs, as required by the position. This position requires standing and frequent walking between production areas to support operations. The role involves working around moving machines, exposure to temperature changes, and compliance with personal protective equipment requirements in designated areas.

NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS

Regular on-site attendance is required for this position, and remote or telecommute arrangements are not available on a temporary, short-term, or long-term basis. The ability to multitask across multiple capabilities and functions, handle competing priorities and requirements, respond to email and phone communications, and attend meetings is essential. Note that these activities may not be restricted to core hours or on-site presence. The position requires effective management of strict production, time, and performance deadlines. Willingness to work beyond regular workday hours, potentially including weekends and holidays, is expected.

***Some travel oversees, vendor qualification testing

#LI- Onsite

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