Lead Operations Industrial Engineer

Unither Pharmaceuticals, LLC

ROCHESTER, NY

JOB DETAILS
SKILLS
Analysis Skills, Change Control, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Data Collection, Data Entry, Develop Methodologies, Document Management, Documentation, Documentation Standards, Engineering Management, Ergonomics, Furniture, Identify Issues, Industrial Development, Industrial Engineering, Industrial Management, Lean Six Sigma, Maintain Compliance, Manufacturing/Industrial Processes, Mentoring, Operational Audit, Operational Support, Operations Processes, Organizational Skills, Performance Analysis, Performance Metrics, Problem Solving Skills, Procedure Development, Process Flow, Process Improvement, Process Quality, Quality Management, Quality Metrics, Resolve Customer Issues, Staff Training, Standard Operating Procedures (SOP), Team Lead/Manager, Technical Support, Time Management, Training/Teaching, Validation Documentation, Zoning
LOCATION
ROCHESTER, NY
POSTED
30+ days ago

JOB SUMMARY

The Lead Operations Industrial Engineer will serve as a key liaison between the Engineering Operations and Production Maintenance teams driving continuous improvements in manufacturing processes. Responsibilities include managing the Industrial Engineering team, analyzing operations data, designing workflows and production processes, reducing inefficiencies, and ensuring that final products meet the established quality standards. The position also involves applying Lean Six Sigma and other methodologies to enhance cost efficiency while maintaining high-quality product standards. Additionally, this position will document processes, develop troubleshooting methods, and provide training to team members to ensure standardization and operational excellence. Collaboration with cross-functional teams, managing KPIs, and implementing new technologies or processes will also be key components of this role.

ESSENTIAL FUNCTIONS RESPONSIBILITIES

Operations Support

• Participate in the writing of procedures for Operations activities linked to new equipment and processes. • Work with Manager and HR Department to implement training plans adapted to specific user profiles. • Determine and help ensure necessary documentation is in place, maintained, and organized (e.g., troubleshooting guides, Process Flows, SOPs, etc.). • Develop and implement process improvements and technological upgrades. • Develop and implement Visual and Production documentation standards in cooperation with management and user personnel.

5S floor zoning furniture line flow

• Familiarize self with different key equipment, participation in the set-up and testing, and determine good practices of use parameters methods. • Train staff for new processes and provide instructions and manuals.

Represent Operations on Site Projects

• Actively participate in the definition of needs in URS for both functional and technical specifications. • Represent plant operations during industrialization of new equipment line. • Review and approve Qualification and Validation documents. • Define and Lead action plan as necessary to get the equipment to match the expectations of the URS once installed and qualified. • Identify users and access levels required based on department and specific needs. • Assist in the design and implementation of LEAN practices, VSM, Continuous flow, Workplace organization, 5S Cycle time, takt time studies, Ergonomic, Define Waste, TPM program.

Identify areas for improvement by collecting data or with input from the Operations Department.

Management of Industrial Engineering Team

• Supervise, mentor, and develop the Industrial Engineering team, ensuring they have the necessary skills and resources to succeed. • Assign continuous improvement projects and tasks to Industrial Engineering Technicians and monitor workload and outcome. • Organize the department to be able to address continuous improvement initiatives as they are identified.

Team That Consistently Delivers

• Ensure regulatory compliance. • Assist supervisors and direction to staff and coordinates workflow within the work unit based on new equipment and process improvements. • Provide technical assistance, positively answer users questions, and request for support in resolving problems. • Keep abreast of all new technical knowledge and developments that impact performance and relay information to the Operations team. • Assist lead the resolution of deviations by obtaining root cause and corrective actions in a timely manner with no disruption to operations activities. • Implement both short- and long-term corrective actions and process improvements to ensure continued compliance. • Assist with developing quantitative techniques to monitor process performance KPI. • Analyze management information and continuous quality improvement data to identify ways to streamline, improve process quality, and/or compliance while maintaining process effectiveness. • Ensure that all change control documentation is implemented in a timely manner. • Ensure stakeholders are appropriately trained on the process and any process changes.

About the Company

U

Unither Pharmaceuticals, LLC