Cynet Systems
Job Description: Pay Range: $23hr - $28hr Responsibilities: Operational Activities: Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. Modifies or update CMMS documentation as required. Prepares reports and keeps records on calibration inspection, testing, and repairs. Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. Ensures all calibration, PM, and performance verification records are filed appropriately after approval. Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards Initiates, participates, and assists in resolution of quality investigations. uthors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. Supports the development, review and approval of calibration and maintenance plans in site CMMS system. Supports the execution of process improvement studies, as required. dheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. Performs inventory of the equipment and/or standards in the labs as required. Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. Participates actively in special projects as required. Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas) Plans, justify and implement cost reduction small projects. Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.) Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. Support the development, review and approval of calibration and maintenance plans in site CMMS system. Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management: Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. Perform Client's investigations. Regulatory Responsibilities: Maintains all required Corporate, Facilities and EHS training as required. dheres to all safety procedures and hazard communication. Education And Experience: High school Diploma or Associates or Bachelor's degree. 3+ years of lab experience preferred in pharma or medical device industry or manufacturing. Working Conditions: Physical Requirements (Due to the nature of the job): Occasional stooping, bending, stretching, pushing, pulling, reaching, and/the candidate should be able to lift 20 pounds with assistance. bility to sit, stand, walk, and move within workspace for extended periods. bility to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling. Environmental Conditions: Environment may include working in office, laboratory, or manufacturing area. Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required. Working safely and effectively when working alone or working with others will be required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. dditional Job Requirements: Position Handles Hazardous Materials.