Process Engineer #4230 - The Staffing Resource Group, Inc (Westwood)
The Staffing Resource Group
415 Old Tappan Rd
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Process Engineer (Equipment):
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent. ? Title: Process Engineer (Equipment) ? Location: Somerset, NJ ? Industry: Pharmaceutical ? Hours: Monday-Friday; 8:00 am 5:00 pm ? Salary: $50.00-$55.00 hour paid weekly with benefits options ? Employment Type: Contract 12 months with possible extension or conversion Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products. Isn t this the type of company you want to work for?
Job Scope: This position is responsible for providing technical support, coordination and expertise for new technology introductions, packaging automation, and other existing technologies. This position will have direct responsibility for ensuring that GMP, Safety, and other regulatory considerations are clearly developed and implemented in the associated procedures, preventive maintenance records, engineering controls and maintenance processes. This position will develop key process engineering/maintenance data sets, spare parts procurement/control, FMEA studies, and process and facilities control mechanisms to develop performance optimization. ? Leads in providing innovative solution as they pertain to processing unit operations in the Somerset site focusing on process optimization, automation and efficiency ? Creates and monitor key equipment performance metrics such as equipment downtime and reject trends ? Uses statistical thinking and methods to understand process variability and capability and drive process improvements ? Determines process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases ? Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure ? Guides the specification and selection of manufacturing/utility equipment to support the process needs ? Responsible for the design and implementation of the process systems ? Works with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment ? Evaluates PMs and SOPs to ensure that they reflect current practices and they are executed optimally to meet performance expectations ? Interfaces with Project Engineers and end users to maintain and control hardware and software of process unit operations ? Assignment of and management of process and facilities related Deviations, CAPAs, and Change Controls ? Responsible for working with the Original Equipment Manufacturers (OEM) to acquire expert knowledge for transfer internally and personal growth ? Leads the implementation of new equipment, policies and/or procedures ? Works on highly complex problems where analysis requires evaluation of factors of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria. Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought ? Coordinates activities with Operations team to ensure proper prioritization. ? Determines approaches to be utilized for assigned projects, then plans and executes work independently with minimal supervision. ? Takes a leading role in assuring the successful timely scale-up and transfer of formulations and processes from pilot plant to full-scale production, for either incoming or outgoing products related to new technology in Operations ? Makes suggestions, recommendations, and contributions to process development and supports manufacturing activities for pharmaceutical products in a CGMP facility ? Serves as a technical liaison for internal or external customers regarding manufacturing operations on new or existing product development ? Recommends process and procedure changes designed to increase efficiency, safety, and/or quality ? Remains flexible with respect to maintenance priorities and ensures that site and overall engineering departmental business objectives are met ? Supports the long-term goals of Somerset Site Operations as defined by the Department Heads and General Manager ? Provides support to QA for manufacturing activities involving equipment, processes, calibration, and equipment qualification ? Interprets, evaluates, communicates, and properly documents the results of all work and makes recommendations for action ? Prepares reports and presentations on project progress as well as specifications, procedures, and SOPs Skills Needed: ? Bachelor s Degree with concentrated studies in Engineering (Process, Mechanical, Chemical, Pharmaceutical) ? 5+ years experience working with a cGMP manufacturing or pharmaceutical products facility that provide a working knowledge base of properties, theories, and manufacturing and packaging processes associated with manufacture and packaging of pharmaceutical products and contract manufacturing. ? Basic knowledge of Lean Six Sigma and FDA cGMP s preferred ? Experience applying Six Sigma and Lean techniques in a transactional environment ? Proficient and Exceptional Skills in Microsoft Office Tools: Excel, Access, Word, PowerPoint and Visio required ? Proficient in AutoCAD & SCADA systems ? Proficient in use of Minitab statistical software EOE/ADA