Process Engineer
Janssen Cilag Mfg. LLC, a member of Johnson Johnson's Family of Companies, is recruiting a Process Engineer, for the Parenterals operations in the facility located in Gurabo, Puerto Rico.
The Process Engineer will continuously look for process improvements within the Parenterals Manufacturing processes. Understand process requirement for and evaluates equipment, systems and procedures to ensure processes meets or exceed specifications and quality standards. Will also identify process improvement initiatives and develops proposals for problem solving, improvement or optimization. Provides technical support to the production areas in evaluating process deficiencies, process changes, modifications and equipment failures. Participates/lead in troubleshooting efforts on equipment and process related issues and deviation investigations. Assist in the development of more effective operational control systems. Implements methods to systematically evaluate manufacturing process and equipment problems, analyze process data from equipment failures and make recommendations to prevent reoccurrences. Establish the machine standard hours and Overall Equipment Efficiency (OEE) systems. Responsible for the development and/or revision of production standards for manufacturing and packaging areas within the Parenterals Manufacturing facility. Responsible for the KPI system and the development of improvement initiatives to meet the operation objectives.
Qualifications
A Bachelor Degree in Mechanical, Chemical or Electrical Engineering is required. MBA or MS is preferred. Minimum of six (6) years of experience in the pharmaceutical Parenteral industry environment, four (4) of them executing as Process Engineer. Broad knowledge of technical support writing,cGMP's, FDA regulations, Aseptic Process, Lyophilization technology, Pharmaceutical/formulation process and Parenterals manufacturing equipment is required. Knowledge of process development and optimization, equipment troubleshooting, utilities and environmental controlled areas is required. Yellow Belt is required, Green Belt is preferred. Excellent oral and written communication skills in English and Spanish. Computer skills and use of software applications is required including proficiency in MS Office programs.
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