Description

Sr Engineer Processing

Summary :

Facilitate Compounding operations in continuous improvement activities. Team collaboration with multiple departments toward formulation process improvements. Develop and coordinate processes and procedures within regulatory compliance and adherence to cGMP. Improve consistent product quality performance and reduce cost through analysis of manufacturing methods, processes and optimum utilization of personnel and other resources. Improve safety, reduce waste while stream-lining processes throughout the operation.

Essential Duties and Responsibilities:

• Assessing the operation to determine corrective and preventive action plans geared towards continuous improvement.
• Ensure the department's compliance with ATF, FDA, OSHA, and other regulatory policies. Develop and implement procedures that follow all regulatory agency requirements.
• Participate in the development and implementation of an organized training program for all compounding personnel in the technical aspects involved with the operation. This training includes new personnel and upgrades for more experienced personnel.
• Collaborate closely with Research and Development, Quality, Engineering in the implementation of new products or processes. Transfer knowledge obtained to all department employees.
• Support and maintain an atmosphere that encourages continues improvement and team based problem solving.
• Design, identify, and/or investigate new technologies that will result in process improvements and support both short and long term goals.
• Analyze existing production methods, recommend and implement approved modifications necessary to improve product quality, reduce cost, streamline the manufacturing process, reduce cycle time and optimize utilization of personnel and other resources.
• Direct and assist in conducting root cause analysis. Assist in the development of corrective action training programs as a result of root cause analysis.
• Communicate with company personnel on projects, priorities, timetable and budgets, as necessary.
• Ensure that required formula batches are consistently performed Right First Time and identify opportunities for improvement.
• Streamline formula batches to insure team compounds exactly to compounding process instruction in most safe, quality, efficient manner.
• Investigate and improve batching effectiveness and productivity yields.
• Provide leadership to and mentor Engineer Processing

Supervisory Responsibilities:

Education Requirements:

Minimum Bachelor's Degree Engineering

Experience Requirements:

Seven to ten years' experience in a similar role within a manufacturing environment showing progressive ability to interact and communicate well with people. Must exhibit ability to analyze data and create/implement improvement programs.

Competencies:

• Knowledge of chemistry necessary.
• High degree of continuous improvement and demonstrated problem solving ability.
• Must have thorough understanding of manufacturing practices, including cGMP and FDA regulations.
• Excellent written and verbal communication skills required.

Certificates, Licenses, Registrations:

N/A

Travel:

Work Environment:

Worker exposed to typical production plant conditions, including some inside and outside conditions. Worker exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker occasionally exposed to some atmospheric conditions.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Light physical work. Employee required exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force frequently of move objects.