Process Engineer

2 weeks ago

Stoneham, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

Coordinate and implement process and utility equipment maintenance and troubleshooting in accordance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).

Key Responsibilities

  • Subject Matter Expert for Inspection, Labeling, and Packaging Equipment
  • Experience with SAP, Tracelink, Optel, Bartender, and/or related software/systems
  • Maintenance and operation of process equipment and associated documentation
  • Support execution of preventative maintenance of pharmaceutical process equipment and utilities
  • Ensure equipment is prepared to support production schedule and is in proper condition/calibration
  • 24/7 operational coverage for manufacturing equipment and utilities
  • Support production personnel on equipment and utility operation
  • Support re-qualification of process equipment, testing & certifications of manufacturing process
  • Follow up on equipment/utility related CAPAs, Deviations, and Investigations
  • Review process utilities and equipment logs
  • Support loading / Lyophilizer cycle and coordination of equipment
  • Troubleshoot and remediate exceptions found during production
  • Timely closure of equipment/utility related CAPAs and/or Change Controls
  • Support Validation of equipment/utilities/process transfers and re-qualifications
  • Support URS/FS/DS engineering documents of process related systems
  • Designs, develops, under supervision all aspects of electrical control systems, equipment, (including HMI and PLC code), based on approved PID's
  • Responsible for the installation and technical support of PLC based hardware and software

Work Environment

Office, Lab, Manufacturing area/clean room area/utility area, Maintenance Shop


Physical Requirements
  • Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
  • Climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
  • Close vision; ability to adjust focus
  • Operate computer/office machines, autoclave, Depyrogenation oven, vial filler, freeze dryer, steam generators, power tools
  • Wear proper gowning and safety equipment as needed
  • Lift up to 50 lbs.

Education and Job Qualification
  • Bachelor's in Engineering Electrical/Electronic field preferred or equivalent experience
  • Minimum 2+ years proven PLC/HMI troubleshoot experience
  • Ability towards process coding preferred
  • Ability to oversee cGMP validation compliance efforts
  • Familiarity with FDA cGMP, SOPs and ISO standards
  • Knowledge of Aseptic pharmaceutical manufacturing equipment and utilities
  • Familiarity/Knowledge of aseptic filling Isolators, Lyophilization, CIP and SIP
  • Excellent organizational skills
  • Knowledge of project management for small to medium size projects
  • Knowledge of operating and maintaining secondary packaging machine (Auto Capper, Auto labeler, Auto Cartonner)