Process Engineer

7 days ago

Billerica, Massachusetts, United States Sun Pharma Full time
Job Summary

As a Process Engineer at Sun Pharma, you will play a critical role in ensuring the smooth operation of our manufacturing equipment and utilities. Your expertise in electrical control systems, PLC programming, and HMI design will be essential in maintaining and troubleshooting our complex systems.

Key Responsibilities
  • Coordinate and implement process and utility equipment maintenance and troubleshooting in accordance with cGMPs and SOPs.
  • Provide subject matter expertise for inspection, labeling, and packaging equipment.
  • Experience using SAP, Tracelink, Optel, Bartender, and related software systems.
  • Responsible for 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 schedules and is in proper condition/calibration.
  • Provide 24/7 operational coverage for manufacturing equipment and utilities.
  • Support production personnel on equipment and utility operation.
  • Support re-qualification of process equipment, testing, and certifications of manufacturing processes.
  • Support area manufacturing and new product/process transfer activities.
  • 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.
  • Ensure 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.
  • Design, develop, and implement electrical control systems, equipment, and HMI/PLC code based on approved PID's.
  • Responsible for the installation and technical support of PLC-based hardware and software.
Work Conditions

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 Degree in Engineering (Electrical/Electronic field preferred), or equivalent experience.

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.

Compensation and Benefits

The presently anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. This position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

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