Operations Process Support

Descripción del Empleo:
Responsible for executing manufacturing investigations (QE’s), Corrective Action Preventive Action (CAPA’s),NTR’s, NOE’s, procedures development & revision, and process validation documentation. Acts as facilitator for the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation. Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP’s compliance.
Requisitos:
BS Degree in Industrial Engineering. Five (3 to 5) years of experience in a Parenteral Manufacturing facility. Ability to interpret and analyze statistical data.Knowledge in CGMP’s, OSHA, EPA and other regulatory standards. Knowledge of computers applications (Microsoft Word, Excel, Power Point). Excellent communications skills in Spanish /English Provides operational, scientific expertise and compliance knowledge support to the Manufacturing Sterile Operations.