Process Engineer
4 weeks ago
Job Summary
As a Process Engineer at Sun Pharmaceutical Industries, Inc., you will play a crucial role in ensuring the smooth operation of our pharmaceutical manufacturing processes. Your primary responsibility will be to coordinate and implement process and utility equipment maintenance, troubleshoot issues, and ensure compliance 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
- Responsible for maintenance and operation of process equipment, as well as associated documentation
- Support execution of preventative maintenance of pharmaceutical process equipment and utilities
- Ensure that equipment is prepared to support the production schedule 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 & 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
- Designs, develops, under supervision, all aspects of electrical control systems, equipment, (including HMI and PLC code), based on approved PID's
- Will be 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
- Exposure to noise, hot and cold, outside elements, some radiation
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
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)
The compensation and benefits for this position are competitive and include a base salary range of $98,000 to $119,500, as well as eligibility for the Annual Performance Bonus Plan. Employees also receive various paid time off benefits, including vacation time and sick time. The company offers a comprehensive benefits package, 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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