Operations Engineer

Position Summary

Optimizes products and processes by establishing process capabilities and controls to ensure adherence to standards through continuous verification (tactical focus 0-30 days out). Strong problem‑solving skills with the ability to clearly define problem statement, scope, potential causes, identify root cause, and implement short‑ and long‑term countermeasures. Drives key daily quality and reliability metrics, which enable the department to meet its business objectives.

Coach personnel on best practices and techniques to improve First Time Right (FTR) production. Understands key TPM methodologies and can apply correct tools in assigned reliability areas, such as using AM to drive out minor stops. Evaluates/Analyzes data, identifies opportunities, and drives out loss through the PDCA process. Understands and coaches on the PDCA process. Instrumental in investigating NCRs/Customer Complaints by getting to the root cause and implementing robust corrective actions and preventative actions.

Knowledgeable of the change control process. Technical and operational mastery of assigned areas.

• Works cross‑functionally on multiple projects in the areas of equipment, processes, raw materials, primary and secondary packaging components, and specification design and development.
• Primary point of contact for daily process issues.
• In partnership with Packaging Engineering/Technical Operations, research, recommend, improve, and develop, if needed, raw materials/packaging components to accommodate manufacturing/packaging needs for new equipment/product extensions.
• Leads and serves on process improvement cross‑functional teams that address specific operational problems and enable existing manufacturing/packaging processes and equipment to become more efficient/reliable.
• Supports Quality and Operations through troubleshooting, change controls, and Non‑Conformance Report (NCRs)/Customer Complaint reduction.
• Prepares, reviews, and/or approves technical documents including Quality Change Requests (QCRs), Non‑Conformance Reports (NCRs), Technical Reports, SOPs, Master Batch Records (MBRs), Cost Quotes, Routers, Product and Process Verification/Validation Protocols (IQ, OQ, PQ), P&PV Summary Reports, and Stability Protocols.
• Uses problem‑solving skills to identify root cause and implement short‑ and long‑term corrective actions related to improving the reliability of products or processes.
• Develops a high level of process understanding and capability for manufacturing/packaging processes, and works to optimize the process to maximize customer value.
• Supports periodic review of products and processes by collecting data, analyzing data, and implementing recommendations related to improvements.
• Maintains documentation on all projects and submits written reports in a timely fashion.
• Trains Technical Operations, Product Development, and Manufacturing staff on new processes and/or equipment technologies.
• Performs other related duties as assigned.

Requires a four‑year college or university degree in Industrial Engineering, Mechanical Engineering, Chemical Engineering, or a Food Science degree or equivalent experience.

Certified Packaging Professional, Lean Manufacturing, Six Sigma, or other related problem‑solving tools are a plus.

Four to five years of experience in a manufacturing setting, preferably in packaging.

• Comprehensive knowledge of product and process development, manufacturing/packaging equipment, processing/testing laboratory techniques, and regulatory requirements.
• Firm foundation in chemistry, mathematics, pharmaceutics, and/or food science.
• Well‑developed oral and written communication skills at multiple levels in the Organization.
• Results‑oriented and able to effectively organize and develop plans; prioritize and execute actions.
• Ability to make presentations and recommendations in the assigned area.
• Understanding of Lean concepts and application of Design of Experiment (DOE) and Quality by Design (QbD) are a plus.
• Use of hand‑held data collection devices and instrumentation.

Manufacturing, Pilot Lab, and general…