Manufacturing Engineer
Job Description
ABSOLUTELY NO SPONSORSHIP NOW OR IN THE FUTURE -- NO VISAS OR ANY SPONSORSHIP -- PLEASE DO NOT APPLY
Manufacturing Engineer
Boone County, KY
Position Overview
The Manufacturing Engineer supports production operations by improving manufacturing processes, validating equipment and systems, and identifying opportunities to increase efficiency and reliability within a regulated manufacturing environment.
This role works closely with operations, quality, and technical teams to implement process improvements, support equipment and process validation activities, and ensure manufacturing systems operate in accordance with internal quality standards and regulatory requirements.
The position also supports continuous improvement initiatives and provides technical guidance related to equipment, production workflows, and process optimization.
Experience working in FDA-regulated manufacturing environments with batch processing and filling operations is strongly referred
Key Responsibilities
Process Improvement & Operational Support
- Identify opportunities to improve production efficiency, reduce operational costs, and enhance manufacturing performance.
- Analyze manufacturing processes and recommend improvements related to equipment utilization, workflow, and labor efficiency.
- Participate in cross-functional teams focused on improving manufacturing effectiveness and operational performance.
- Conduct time studies, process evaluations, and workflow analysis to support productivity improvements.
Equipment & Process Validation
- Develop and execute validation protocols for manufacturing equipment and processes.
- Prepare validation documentation including procedures, protocols, and final reports.
- Ensure validation activities meet internal quality standards and regulatory requirements.
- Collaborate with quality and regulatory teams to maintain compliance with applicable standards.
Manufacturing & Automation Support
- Support implementation and integration of new production equipment and manufacturing technologies.
- Assist in evaluating equipment performance and identifying opportunities for improvement.
- Support automated systems and manufacturing equipment used in production operations.
Production Optimization
- Work with operations teams to improve material flow, workstation layout, and production efficiency.
- Support development of standard work processes and manufacturing documentation.
- Help establish process control strategies to ensure consistent product quality.
Training & Technical Support
- Provide training and technical support for manufacturing personnel related to equipment and production processes.
- Develop visual management tools and documentation that support effective production control.
Continuous Improvement
- Participate in root cause investigations and corrective action activities.
- Support continuous improvement initiatives focused on manufacturing efficiency and process stability.
- Apply structured problem-solving methods to improve production performance.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, or related field preferred.
- Approximately 5+ years of experience in manufacturing engineering within a regulated production environment.
- Experience in FDA-regulated manufacturing environments strongly preferred.
- Experience with batching and filling operations in chemical or liquid production environments is required.
- Knowledge of cGMP requirements and regulated manufacturing practices.
- Experience with equipment validation and process validation activities.
- Strong analytical, problem-solving, and communication skills.
- Ability to work effectively within cross-functional teams.
Preferred Experience
- Background in chemical manufacturing, liquid processing, or similar production environments
- Familiarity with EPA or FDA regulatory requirements (including 21 CFR guidelines)
- Experience supporting continuous improvement initiatives within manufacturing operations