Technical Writer 2

Employment Type

: Full-Time


: Miscellaneous

Job Description Responsibilities: * This position provides advanced technical support in manufacturing sustaining efforts in a high volume, consumables manufacturing environment. You will define and perform preventative maintenance on optical, mechanical, electrical and fluidics systems. You will work to improve equipment uptime and reliability. You will also apply organic chemistry principles in troubleshooting manufacturing and equipment process issues. * Provide necessary support to ensure GMP compliance and other regulatory requirements are maintained within production; oversee and verify critical steps and process as defined per manufacturing process and management * In conjunction with LCM Process Engineers, support production areas with yield and quality monitoring, investigation and root cause analysis, and provide coaching and technical leadership for improvements within Manufacturing * Develop and maintain production process maps * Participates in new construction and renovation projects for manufacturing spaces ensuring key milestones and goals are successfully met within the established timeline * Review and make recommendations for design layouts considering how to maximize process efficiencies, capability, and capacity * Assist with the identification, creation and review of project plans initiatives and milestones, ensuring manufacturing, quality and regulatory requirements are met within established project timelines * Write/contribute to the creation of facility and functional specification documents, commissioning and/or validation protocols, process mapping and writing of new work instructions or updating of existing work instructions, in order for successful startup of operational activities within new manufacturing spaces * Assist with the identification, planning, and procurement of manufacturing related items (equipment and supporting materials) needed for the space * Collaboration with LCM and MFG, manage change controls for existing production processes and documentation, including * Initiating and/or overseeing change control requests * Coordinating timelines and appropriate delegation of activities to cross functional groups with respect to change control * Ensure all tasks are completed * Drive continuous improvement initiatives within MFG as it relates to safety, quality, waste reduction, and production efficiency/capacity * Provide ongoing technical and scientific support for manufacturing process improvements and new product and process transfers * Accountable for identifying and implementing Good Manufacturing practices (GMP) to MFG areas * Participate in Kaizen events as required * Help implement improvement initiatives such as 5S and other lean manufacturing programs * Develop and train new and existing personnel in GMP compliance and production procedures as applicable by their job responsibilities * Some night shift and/or weekend work may be required Requirements: * Experience in a production and/or product development preferred. * Experience in a cGMP environment highly desired, in applying best work practices and techniques * Experience in a 21 CFR 820 environment * Must understand the process of control requirements for production and process improvement as per QSR, FDA, ISO 90001/13485, and other regulatory requirements * Experience with Nonconformances, Customer Complaints, Corrective Actions, Preventative Actions, Corrections for manufacturing operations and process. * Desirable to have experience and knowledge of operations of IVDs, medical devices, and/or Pharmaceutical products * Knowledge of Document Control systems, and ERP/MRP control systems (e.g JDE or SAP); highly desirable knowledge of electronic manufacturing batch management systems (e.g. Camstar) * Must have the ability to adapt to rapidly changing priorities and has the flexibility to support operations in accordance with departmental and company schedules and priorities * Excellent communication, interpersonal, and leadership skills * Must be able to independently problem solve within minimum to no supervision, and have a high degree of independence in decision making * Strong understanding of manufacturing methods & terminology Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

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