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Manufacturing Production Supervisor

Cresilon, Inc. New York, NY

  • Posted: over a month ago
  • Nights
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: 1. 2. Position Description: The Production Supervisor leads a sound, efficient, safe, and effective production environment and implements our vision for this business-critical function at Cresilon. The production operations must comply with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). This role also organizes and deploys optimal and cost-effective aseptic manufacturing practices in a fast-paced environment through collaboration with Cresilon suppliers, stakeholders, production engineers and technicians to meet challenging customer demands. The Production Supervisor should have a strong operational, quality, compliance, and technical background, with proven team building, project management, continuous improvement, and supplier management abilities. This is often a hands-on role working closely with production team or other functions, to identify improvements, troubleshoot processes and equipment challenges. This may ultimately become a second shift position, although for training purposes only work hours will be during first shift (7am-4:30pm) for the most of 2021. Responsibilities: Plans, organizes, and leads batch production operations and associated production activities to maintain quality, cost, and customer service expectations within a safe working environment. Manages a team of production technicians, in execution of daily work. Ensures technicians comply with established process parameters and standard operating procedures, cGMP regulations and safety requirements. Provides operators with constructive feedback. Performs tasks associated to manufacturing operations in accordance to cGMP/SOP and batch records requirements. Manage operations to assure all products are visually inspected, labeled and packed into their finished containers as per applicable standard operating procedure and specifications including documentation such as batch records, protocols, and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices Supervises the assembly, disassembly, cleaning, and storage of manufacturing equipment. Supervises the cleaning of the sterile room facility. Ensures target production numbers are met and cGMP documents are completed in a timely manner. Acts as a subject matter expert on Manufacturing Practices, including in aseptic behaviors and practices. Implements continuous improvement, leveraging expertise in Six Sigma, Lean or Toyota Production System (TPS) approaches. Adheres to all workplace safety laws, regulations, standards and practices and actively advances a culture of safety within their team and organization. Resolves or escalates any problem occurring in the area that affects product quality, safety, and other aspects of production line performance. Demonstrates the ability to properly operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoot equipment problems to achieve optimum production targets. Establishes a working environment that fosters participation within and between teams. Hires, trains, develops, disciplines and discharge production operators and engineers. Develops, mentors, and supports production operators in driving continuous improvement efforts, improving employee engagement, and supporting business growth. Represents manufacturing on launch teams focused on design and process transfer. Ensures compliance with Quality Assurance and Quality Control requirements and participates in timely investigations and implementation of corrective and preventative action. Ensures records of critical process parameters and documentation are maintained. Generates production batch procedural documentation, manages change assessments, risk assessment reports, process validation protocols and standard operating procedures (SOPs). Creates, updates, reviews, and maintains production-related SOPs. Reviews and approves documents, including standard operating procedures, batch records, material specifications and validation protocols and reports. Leads the execution of the validation master plan for newly transferred or existing products. Leads the continuous improvement of production operations and procedural documentation. Leads the on-going analysis and support of newly transferred and existing products. Examples include, evaluating lifecycle management opportunities, troubleshooting process transfer gaps, identifying root causes, recommending preventative actions, optimizing processes, etc. Implements of new process changes, including commissioning, facility and site acceptance testing, installation and operational qualification, process qualification and process validation. Organizes and leads initial and on-going training of new and existing personnel. Maintains appropriate inventory of production supplies and materials. Schedules and oversees maintenance and repairs to all production equipment and production facilities. Develops and manages budget performance for areas of responsibility. Conducts other responsibilities as required by management. Requirements Bachelors degree with a focus on science or engineering or in place of degree, at least 10 years of commensurable experience. Advanced technical (MS or PhD) and/or business management degree (MBA) is preferred. 10+ years of relevant cGMP manufacturing experience with a strong technical background and experience in cGMP cleanroom operations, including aseptic processing operations, preferred. A minimum of three (3) years supervising hands-on manufacturing operations with direct supervisor responsibility. Strong background in manufacturing operations and GMP quality systems and a variety of production concepts, practices and procedures. Broad knowledge of high-performance manufacturing, FDA regulatory requirements, validation concepts and techniques, is required. Experience with implementing and overseeing for cost reduction initiatives. Experience with lean manufacturing, six sigma, and category management is desirable along with MRP (Manufacturing Resource Planning) systems and production order transaction maintenance. Demonstrated knowledge and proficiency in the Toyota Production System (TPS) preferred. Working knowledge of quality management systems, technical transfer and/or process development procedures is required. Previous experience in any of the following areas is preferred: gel production, fill and finish operations and automated packaging. Requires strong leadership and organizational skills including attention to detail and multi-tasking skills. Able to understand project details but keep overall big picture view of projects, priorities, and strategies. Team oriented with the ability to build relationships and influence and/or enforce decisions with peers and management in a proactive manner. Strong leadership skills with a proven ability to build, motivate and maintain a high performing, cohesive team with the ability to inspire passion and commitment and lead and facilitate operational and cultural change initiatives. Prior experience training technical personnel is required. Proven leadership skills, capability and ability to mentor, coach, and develop a team and other associates and to deliver performance metrics through others Organizational and time management skills with the ability to prioritize a variety of tasks/projects. Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Experience in supporting regulatory inspections and audit readiness activities Experience in applying continuous improvement strategies Ability to expresses ones self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. Requires excellent written and verbal communication and presentation skills. Strong computer skills, including experience with Microsoft Word, Excel, PowerPoint, Visio, and related applications. Working knowledge on business management systems such as SAP Legal authorization to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future is required. Physical Requirements Ability to become gowning qualified to work in a cleanroom environment. Ability to climb, balance, stoop, reach, stand and walk. Ability to bend, twist, push, lift, and grasp. Ability to speak, listen, and understand verbal and written communication. Ability to pass respirator fit test. Ability to work for extended periods of time with appropriate respiratory equipment. Ability to pass a medical evaluation, should one be needed Manual dexterity to perform delicate manipulations. Ability to perform repetitive motions, including substantial movement of wrists, hands, and or fingers. Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. Visual acuity to perform close activities such as:

Cresilon, Inc.


New York, NY



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