Under direct supervision from OPS or Eng. Manager or Sr. Engineer. Performs a variety of engineering assignments in developing, implementing and sustaining production/processing methods and controls to meet quality standards in the most cost-efficient manner. May supervise and provide technical assistance to exempt and non-exempt personnel. Will work closely with engineering and quality teams and have manufacturing responsibility for products at production level. Also, will have the responsibility to qualify equipment or processes on replicated manufacturing lines. Responsible for the approval of procedures change request and qualifications documents. Many projects are broad in nature, the employee uses discretion to design project tasks to bring project to completion.
- Responsible of the daily execution of manufacturing activities to meet established goals for Safety, quality, cost and production
- Accountable for the performance management and supervision of the direct reports including hiring, training and development.
- Support or lead projects or Product Introduction and validation activities from planning to implementation phase including equipment and process qualifications and approval.
- Support or drive change request process to ensure that Mfg. process is meeting proper practices.
- Lead or support identification and investigation of Non-conforming products to identify and eliminate causes, implements controls, and assesses the success of the controls.
- Develop and implement Mfg. systems process/procedures to meet production requirements
- Other duties as assigned.
- Requirements include BS in Engineering ( Electrical, Electromechanical, chemical, as minimum).
- 3-5+ years of working experience on similar roles.
- Able to communicate in English, both written and speaking.
- Knowledge of FDA, GMP and ISO guidelines is required.
- Statistical techniques knowledge (DOE, SPC) is required.
- Computer software knowledge (Microsoft Word, Excel, Power Point)
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