Sun Pharmaceutical Industries, Inc.
Process Engineer
Job Location
Reading, MA, United States
Job Description
Job Summary
Coordinate and/or implement process and utility equipment maintenance and troubleshoot as accordance to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs).
Area Of Responsibility
Subject Matter Expert for Inspection, Labeling and Packaging Equipment
Experience using 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 the 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 process
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
Other duties as assigned
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.
Travel Estimate
Up to 0%
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)
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
Location: Reading, MA, US
Posted Date: 10/5/2024
Coordinate and/or implement process and utility equipment maintenance and troubleshoot as accordance to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs).
Area Of Responsibility
Subject Matter Expert for Inspection, Labeling and Packaging Equipment
Experience using 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 the 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 process
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
Other duties as assigned
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.
Travel Estimate
Up to 0%
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)
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
Location: Reading, MA, US
Posted Date: 10/5/2024
Contact Information
| Contact | Human Resources Sun Pharmaceutical Industries, Inc. |
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