Skip to Main Content

Multiple MFG Roles: Production Operator, Production and Process Engineers

Cresilon, Inc.
New York, NY
  • Expired: over a month ago. Applications are no longer accepted.
Job Description: Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon: https://www.bloomberg.com/news/videos/2014-11-19/bandaid-of-the-future-stops-bleeding-instantly http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en With the expansion of our manufacturing capacity, Cresilon has several critical job opening in our production and process engineering teams. All roles are on-site in Brooklyn, NY. We are looking forward to hiring for the following roles: Please indicate your job of interest in your attached cover letter: 1. Production Support Operator Job Description: The Production Support Operator supports all aspects of the aseptic manufacturing and upstream/downstream processes of Cresilons products. S/he will be trained in clean room operations and aseptic techniques. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will demonstrate steady progress and must possess a willingness and ability to learn all equipment and jobs in the assigned manufacturing operations and sanitation of clean room facilities as required. Production Support Operators are responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP) and Cresilon SOPs. This is a non-exempt/hourly position. Responsibilities include: Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, and packaging equipment. Troubleshoot all operating deviations and issues and coordinate with other functions when required. Report both machine and operating deviations to area supervisor or designee. Perform routine, preventative maintenance on equipment. Perform cleaning and disinfection/sterilization of the manufacturing spaces and equipment. Perform testing of components and product, including visual inspection. Assist production staff to perform in-process and finishing operations including finished goods packaging. Stock inventory of supplies, components, materials, etc. utilizing the Kanban system.. Complete data entry and generate reports for material inventory movements Assist the Production Technicians to perform material receiving, staging, material movements, and material replenishment. Transport samples, materials, and equipment between multiple facilities. Package and ship components for processing or for final distribution. Complete and maintain applicable logbooks and production paperwork as required. Maintain a clean production environment during shift. Report all actual, near misses and potential accidents for further investigation. Assist in the investigation of all actual, near misses and potential accidents, taking immediate action to resolve any near miss situations. Provide information to troubleshoot and take initiative to resolve operational issues independently. Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process. Complete all required trainings and successfully follow Cresilon SOPs in accordance to Good Documentation Practice (GDP) and cGMP. Responsibilities may include other duties as assigned and as required. 2. Associate Production Engineer Job Description: The Associate Production Engineer is responsible for supporting the manufacture of Cresilons products. The Associate Production Engineer will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The Associate Production Engineer will manage projects, author and revise standard operating procedures, work instructions, and investigations, and be required to support production of product. The Associate Production Engineer will collaborate with SMEs from Manufacturing, Quality, and R&D to improve processes as a liaison for Production Technicians on the floor. The ideal candidate will understand statistical process control (SPC) and use SPC and quality data to make data driven decisions when diagnosing, troubleshooting, and improving issues while maintaining frequent communication with Operations, Quality, and other teams as required. Responsibilities include: Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling while ensuring alignment with regulations. Analyze and plan workforce utilization, space and workflow requirements, and design layout of equipment and workspace for maximum efficiency. Manage supply inventory to ensure schedule adherence to the manufacturing plan. Track KPIs to identify opportunities to improve process efficiencies. Contribute and/or Lead LEAN projects within the Production Team (5S, Kaizen, etc.). Provide feedback to Process Engineers regarding equipment design concepts and specification requirements to best align with manufacturing techniques. Support manufacturing production with all required technical needs. Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment. Formulate, fill, and pouch product in accordance with SOPs. Troubleshoot all operating deviations and issues and coordinate with other functions when required. Report both machine and operating deviations to area supervisor or designee. Perform routine, preventative maintenance on equipment. Perform testing of components and product, including visual inspection. Perform in-process and finishing operations, including finished goods packaging. Complete data entry and generate reports for material inventory movements. Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards. Transport samples, materials, and equipment between multiple facilities. Package and ship components for processing or for final distribution. Complete and maintain applicable logbooks and production paperwork as required. Maintain a clean production environment during shift. Report all actual, near misses and potential accidents for further investigation. Assist in the investigation of all actual, near misses and potential accidents, taking immediate action to resolve any near miss situations. Provide information to troubleshoot and take initiative to resolve operational issues independently. Assist in project commissioning and validation activities, as necessary. Prepare samples or prototypes as required for testing, or other evaluations. Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process. Complete all required trainings and successfully follow Cresilon SOPs in accordance to Good Documentation Practice (GDP) and cGMP. Oversee training of junior employees and Production Technicians on production processes as assigned. Ensure proper communication and handing over of shift duties. Support Environmental and Personnel Monitoring (EM/PM) activities as directed. Responsibilities may include other duties as assigned and as required 3. Production Engineer I Job Description: The Process Engineer I is responsible for leading process development and design, engineering, installation, optimization and operation activities in compliance to all quality and regulatory requirements. Process development generally originates in a R&D environment and may be followed by technology transfer and by qualification into manufacturing. The Process Engineer I will work in a multidisciplinary team engineers, scientists, and other parties as needed. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of innovative, yet compliant and robust processes. The Process Engineer I is expected to be knowledgeable in the design and development of processes, and operation of this equipment. This expertise may include, but not limited to: polymer, biomedical, chemical, material science or mechanical engineering. The Process Engineer I will support creating documentation necessary for regulatory submissions and communicating directly with the Director of Process Engineering on all other tasks. Responsibilities include: Exercise technical judgment in the design, execution and interpretation of process and formulation data within the scope of project responsibilities. Additionally ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods, sound engineering practices and procedures. Supports material/design/process changes through design control process, with well-documented research/analyses. Author protocols and reports including engineering studies and design verification/validation activities. Prepare samples as required for testing, or other evaluations and data analysis. Interface with external vendors on design components; interface with customers, supplier and internal cross-functional team members to develop specification and coordinate prototype fabrication. Lead new equipment/process implementation as well as process and product transfers to manufacturing. Maintain a laboratory notebook and other technical documentation according to good engineering practices and required GMP guidelines. Understand and prioritize process improvements. Particip

Cresilon, Inc.

Address

New York, NY
USA

Industry

Manufacturing

View all jobs at Cresilon, Inc.