Manufacturing Advance Engineer

Kindeva Drug Delivery
ROLE SUMMARY
The Manufacturing Advance Engineer plays a crucial role in ensuring consistent high performance of manufacturing equipment and processes. This position focuses on driving quality into production processes, implementing best practices, and continuous improvement. The incumbent will provide process ownership and technical expertise to ensure the production of high-quality medical device products. The Manufacturing Process Engineer collaborates with Management, Supervision, and Production colleagues to identify and implement innovative solutions. Additional responsibilities include ownership of pFMEAs, project management, application of Six Sigma methods, and coordination of training.
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.
• Collaborate with Operations, Quality Assurance (QA), Operational Excellence (OPEX), and other internal experts to develop quality investigations, determine root causes, and implement corrective and preventive actions (CAPA).
• Investigate process deviations on the manufacturing floor using structured Six Sigma-based methods.
• Develop and execute manufacturing protocols and machine trials as needed to support Compliance and Continuous Improvement projects.
• Represent manufacturing as an individual contributor on assigned project teams to ensure the successful completion of key initiatives.
• Act as an internal technical training resource for Operations Management and production floor teams.
• 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.
BASIC 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:
• 5-10 years of experience in pharmaceutical manufacturing and a background in manufacturing or quality.
• Previous experience in pharmaceutical manufacturing preferred.
• 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 Meridian Medical Technologies' 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.
California residents should review our Notice for California Employees and Applicants before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.