Maintenance Technician

Kashiv BioSciences, LLC•Piscataway, NJ

28d•Onsite

About The Position

The Maintenance Technician is a regular employee in a full-time non-exempt position with the Engineering department at Kashiv BioSciences, LLC, in Piscataway, NJ. This position is responsible for Maintenance, calibration and continuous improvement activities for Kashiv’s manufacturing, equipment, utilities and facilities to establish consistent production output while keeping down-time to a minimum and improving reliability over time. General responsibilities will include but are not limited to the following: Plan, perform and ensure manufacturing / major laboratory equipment preventive maintenance according to plan, troubleshooting, corrective maintenance, calibration and environmental monitoring in compliance with technical standards, SOPs and applicable regulation Plan and schedule compliant maintenance of utilities/facilities with third party service providers; Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for facility projects Coordinate procurement of spare parts and equipment in line with established processes, ensuring availability for planned maintenance and unplanned repair Evaluate, in conjunction with QA, the requirement for change control assessment/process for any equipment/facility/utility changes Support and/or perform investigations / deviations from an engineering/maintenance perspective and own timely execution of resulting CAPAs in area of responsibility; Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements Ensure that preventive maintenance, calibration and corrective maintenance records are properly documented, filed and/or archived. Support Engineering Department on any internal and/or external audit with requested documents Performs other functions as required or assigned Complies with all company policies and standards

Requirements

A minimum of 5 years of manufacturing experience in a regulated environment, in a maintenance/engineering capacity is required
Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
Plan and schedule compliant maintenance of utilities/facilities with third party service providers
Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for projects
Willing to work long hours and weekends as needed to assure that the manufacturing operations are not affected.
Work with minimum supervision and willing to learn new skills.
Good communication and interpersonal skills to interact with co-workers, management and the general public sufficient to share or transmit information and receive or deliver work guidance.

Responsibilities

Plan, perform and ensure manufacturing / major laboratory equipment preventive maintenance according to plan, troubleshooting, corrective maintenance, calibration and environmental monitoring in compliance with technical standards, SOPs and applicable regulation
Plan and schedule compliant maintenance of utilities/facilities with third party service providers
Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for facility projects
Coordinate procurement of spare parts and equipment in line with established processes, ensuring availability for planned maintenance and unplanned repair
Evaluate, in conjunction with QA, the requirement for change control assessment/process for any equipment/facility/utility changes
Support and/or perform investigations / deviations from an engineering/maintenance perspective and own timely execution of resulting CAPAs in area of responsibility
Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements
Ensure that preventive maintenance, calibration and corrective maintenance records are properly documented, filed and/or archived.
Support Engineering Department on any internal and/or external audit with requested documents
Performs other functions as required or assigned
Complies with all company policies and standards