Calibration Technician

Job Number: 26-00301

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Calibration Technician for our client in Warren, NJ
. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

• 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.

• 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 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.
  • Supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
• Regulatory Responsibilities:
  • Maintains all required Corporate, Facilities and EHS training as required.
  • Adheres to all safety procedures and hazard communication.
  • May be called upon to act…