| Job Description: |
Lead mid to large size aseptic processing.
* Responsible for process validation of aseptic processing area.
* Work with internal and external customers (Quality, Engineering, Supply Chain, Manufacturing, Technical Services, Marketing and Purchasing) to develop robust and cost effective packaging, which will satisfy all customer requirements.
* Identify and lead the implementation of innovative aseptic processing techniques to increase manufacturing yield and reduce cost.
*1.
* Establish standards for technical excellence in the aseptic filling operation.
* 2.
* Monitor and report process yields, cycle time and variability.
* Use Six Sigma DMAIC, Lean and other tools to better understand the filling processes.
* Identify and lead projects to improve yields and process efficiency, increase throughput and reduce variation.
* 3.
* Lead problem-solving efforts and investigations of process shifts when necessary.
* Evaluate product impact.
* 4.
* Evaluate and implement new technologies to improve production.
* Lead the transfer of new processes into the area.
* 5.
* Maintain the collaborative relationship with partnering organizations such as Manufacturing, Quality, Regulatory, Engineering, Supply Chain, etc.
* 6.
* This position will have some direct reports.
* He/she is responsible for their growth, development and retention.
*7.
* Understanding of container closure validation and glass fracture analysis.
*
Requirements
1.
* Must have experience in aseptic filling operations.
* Must be familiar with pharmaceutical filling equipment and procedures.
* Some experience with lyophilization desirable.
* 2.
* Must have some experience supervising and developing others.
* 3.
* Must have experience leading teams and managing projects.
* 4.
* Must have some knowledge of validation, quality systems, cGMP and other regulatory requirements in a pharmaceutical manufacturing setting.
* 5.
* Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools.
* 6.
* Ability to communicate effectively using a wide variety of skills and vehicles.
* 7.
* Ability to negotiate and maximize the effectiveness of resources; influence others internally and externally.
* 8.
* Knowledge of Six Sigma DMAIC and Lean preferred.
* Bachelor's degree in an engineering discipline, Chemical Engineering or Mechanical Engineering preferred, with at least 6 years of relevant experience, MS with at least 4 years, or PhD with at least 2-3 years of relevant experience.
*Percent Travel Required0%
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