Noramco, Inc. a subsidiary of Johnson & Johnson produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics and pharmaceutical intermediates. The Noramco, Inc site is centrally located in downtown Wilmington, Delaware accessible by local transportation and SEPTA.
The Process Engineer utilizes scientific, engineering and other technical resources/skills to support active pharmaceutical ingredient production. The position responsibilities include the overall Project Management for product transfers or process improvement efforts including initiating the project, initiation of all Management of Change Documentation including regulatory strategy form, preparing the project plan, and preparing capital documentation as required. Prepare any technology transfer documentation along with providing process engineering support to Chemistry Services during the development work. Determining Plant implementation needs (i.e. what equipment is needed to make product). Preparing Mass Balance based on chemistry. Preparing Final process flow diagrams and block flow diagrams for the conceptual design documentation. Develops Energy Balance (calorimetric report). Performing Cycle Time Analysis as well as determining Vessel Vent Relief Adequacy. The Process Engineer prepares Conceptual Design Reports. Assists engineering with the development of the Process Engineering Specifications and serving as internal consultant to production supervisors on all technical and engineering aspects of operation. She/he writes Standard Operating Procedures, batchlogs, process and cleaning validation documentation. Troubleshoots and organizes solutions for processing and equipment problems and writes reports of the findings. Reviews processes and takes action to ensure that cGMP and Safety procedures and regulations have been addressed and followed. She/he develops and evaluates new concepts to stay competitive and current with industry trends. Specifies design parameters for equipment required for new initiatives and validates processes and also performs Process Hazard Analyses.
Additional position responsibilities: Conducts training for production staff, Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA comply with all company and site policies and procedures. She/he understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements. The Process Engineer is able to make a positive contribution as demonstrated by:
Making suggestions for improvement, and provide overtime as needed, learning new skills procedures and processes. Remain current in skills and industry trends. Successfully completes regulatory and job training requirements and participating on investigative teams and site group initiatives (e.g. PHAs, PSC, etc.). Is available for other duties as required.
Bachelor's degree (B. S.) from four-year College or university in Chemistry or Chemical Engineering required. Ability to read, analyze, and interpret complex scientific and technical journals required. Ability to respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community is strongly preferred. Effectively present information to top management, public groups, and/or boards of directors is preferred. Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations are required. Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis required. Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems is strongly preferred. Deal with a variety of abstract and concrete variables. Ability to use a wide variety of software and hardware, customizing and troubleshooting to meet business needs is required. Knowledge of Excel, Word, SAP (or other ERP system), Microsoft Project, Power Point are preferred. Works well with others in a team environment preferred. Performs a variety of tasks while maintaining speed and sustained attention to detail without a loss of production strongly preferred. While performing the duties of this job, the employee is regularly required to sit, use hands to finger or feel and reach with hands and arms. The employee frequently is required to talk or hear. Must be able to qualify for respiratory protective equipment use. Must be capable of moving around the plant to perform on-site investigations. Shift work may be required.
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