Calibration Technician
il y a 3 jours
Warren
Job DescriptionJob Title: Calibration Technician Location: Warren, NJ 07059 Duration: 12 Months+ (Possible Extension) Pay Rate: $28.48/hr. on W2 Responsibilities: The duties/responsibilities shall include but not limited to the following: • 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°ree;C / -80°ree;C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas)., • Supports multiple sites within Warren., • 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., • Authors 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., • Adheres 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.), • 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., • Maintains all required Corporate, Facilities and EHS training as required., • Adheres to all safety procedures and hazard communication., • Knowledge of cGMP and good documentation practices., • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment., • Strong problem-solving skills and the ability to work independently., • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required., • Strong multi tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously., • Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications., • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred., • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups., • High school Diploma or Associates, or Bachelor's degree., • Minimum 3 years of experience in FDA-regulated industry., • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.), • Maintenance coordination / planning experience preferred., • Physical / Mental Demands:, • Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs., • Ability to sit, stand, walk, and move within workspace for extended periods., • 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. #sczr2