Technician, Operations

MSDWilson, NC
1d

About The Position

Job Description Responsibilities may include but are not limited to; Supports production activities in the manufacture of material. Works in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for production. Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product. Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery. Performs general maintenance and assists or ability in troubleshooting of equipment independently. Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production. Performs sampling/in-process testing supporting the manufacturing and validation process for current process. Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required. Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. Self-motivated to maintain own training status First responder to challenges with packaging equipment: Determine if the challenge is due to the equipment or the component being run on the equipment Gather/Document key information at time of the challenge to aide in current and if necessary, future trouble shooting activities Make minor equipment adjustments as needed to return the equipment to a functional state Document activities using the computerized maintenance management system Use technical manuals for troubleshooting/verification of proper set-up and functionality Leverage vendor training when troubleshooting Escalate to Maintenance when the challenge/issue has not been resolved within the expected timeframe or requires modification of control systems, electrical troubleshooting, advanced troubleshooting or significant equipment failure has occurred. Prepares and maintains packaging equipment for production according to SOPs and GMPs: Clear/Clean packaging equipment Inspect packaging equipment post cleaning Setup and Adjust the equipment Use appropriate tools Ensure proper alignment Ensure proper clearances Partners with maintenance personnel to assist with non-routine equipment repairs, including helping with repairs under guidance of maintenance, initiating work orders and retrieving parts from the stockroom as required. Provides occasional assistance to maintenance personnel that are executing PMs in order to develop a better operational understanding of the equipment functionality Education Minimum Requirement: High School diploma or equivalent and 2 years maintenance experience with a focus in industrial, pharmaceutical, food industry, and/or laboratory equipment OR An applicable Associate's Degree.

Requirements

  • High School diploma or equivalent and 2 years maintenance experience with a focus in industrial, pharmaceutical, food industry, and/or laboratory equipment OR An applicable Associate's Degree.
  • Minimum 1-year relevant work experience in GMP environment
  • Demonstrated written and verbal communications skills
  • Proficiency with GMP gowning for required classifications as needed for role
  • Must be willing and able to lift 50 lbs
  • Must be willing to work shift schedules which may include working every other weekend.
  • Accountability
  • Accountability
  • Automation
  • Biopharmaceutical Industry
  • Calibration of Equipment
  • Communication
  • Computer Literacy
  • Equipment Maintenance
  • Equipment Repairs
  • Facility Maintenance
  • GMP Compliance
  • Inventory Management
  • Lean Manufacturing
  • Lean Six Sigma (LSS)
  • Manufacturing Quality Control
  • Manufacturing Support
  • Mechanical Maintenance
  • Operations Management
  • Packaging Equipment
  • Packaging Machinery
  • Packaging Processes
  • Preventive Maintenance
  • Process Optimization
  • Production Reports
  • Production Scheduling

Nice To Haves

  • Bioworks Certificate or Associates Degree in science or related field, in addition to minimum required experience and skills
  • Experience training others through hands-on training
  • Experience with automated systems (MES, SAP, DeltaV)
  • Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
  • Demonstrated ability to work both independently and as a part of a team

Responsibilities

  • Supports production activities in the manufacture of material.
  • Works in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for production.
  • Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
  • Maintains, inventories, and transports all required equipment, materials, supplies and products.
  • Ensures shipment criteria and timely availability and delivery.
  • Performs general maintenance and assists or ability in troubleshooting of equipment independently.
  • Performs housekeeping in all work areas.
  • Executes facility decontamination according to procedures.
  • Maintains, cleans and prepares equipment used in production.
  • Performs sampling/in-process testing supporting the manufacturing and validation process for current process.
  • Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
  • Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
  • Self-motivated to maintain own training status
  • First responder to challenges with packaging equipment: Determine if the challenge is due to the equipment or the component being run on the equipment Gather/Document key information at time of the challenge to aide in current and if necessary, future trouble shooting activities Make minor equipment adjustments as needed to return the equipment to a functional state Document activities using the computerized maintenance management system Use technical manuals for troubleshooting/verification of proper set-up and functionality Leverage vendor training when troubleshooting Escalate to Maintenance when the challenge/issue has not been resolved within the expected timeframe or requires modification of control systems, electrical troubleshooting, advanced troubleshooting or significant equipment failure has occurred.
  • Prepares and maintains packaging equipment for production according to SOPs and GMPs: Clear/Clean packaging equipment Inspect packaging equipment post cleaning Setup and Adjust the equipment Use appropriate tools Ensure proper alignment Ensure proper clearances
  • Partners with maintenance personnel to assist with non-routine equipment repairs, including helping with repairs under guidance of maintenance, initiating work orders and retrieving parts from the stockroom as required.
  • Provides occasional assistance to maintenance personnel that are executing PMs in order to develop a better operational understanding of the equipment functionality

Benefits

  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
  • We offer a comprehensive package of benefits.
  • Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
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