Process Engineer

2 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 PLC/HMI troubleshooting, electrical control systems design, and aseptic manufacturing processes will be invaluable in maintaining our high standards of quality and compliance.

Key Responsibilities
  • Coordinate and implement process and utility equipment maintenance and troubleshooting in accordance with cGMPs and SOPs.
  • Provide 24/7 operational coverage for manufacturing equipment and utilities.
  • Support production personnel on equipment and utility operation, and 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.
  • Design, develop, and implement electrical control systems, equipment, and software based on approved PID's.
  • Install and provide technical support for PLC-based hardware and software.
Requirements
  • Bachelor's Degree 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.
Benefits

SUN PHARMA offers a competitive compensation package, including a base salary range of $98,000 to $119,500, and eligibility for the Annual Performance Bonus Plan. Employees also receive various paid time off benefits, including vacation time and sick time, and participate in Company employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and the employee assistance program.


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