Lead Operations Industrial Engineer

Job Summary

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives for as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow‑Fill‑Seal, Liquid Stick‑Packs, Pharmaceutical bottles, Tablets and Capsules.

It has more than 300 employees.

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.

• Participate in the writing of procedures for Operations activities linked to new equipment/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.

• 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/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 (Operations and Maintenance).

• Supervise, mentor and develop the Industrial Engineering team ensuring they have the necessary skills and resource 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.

• Ensure regulatory compliance.
• Assist supervisors and direction to staff and coordinate workflow within the work unit based on new equipment/process improvements.
• Provide technical assistance, positively answer users' questions and request for support in resolving problems/external analysis.
• 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‑…