Process Engineer
Company: Sun Pharmaceutical Industries, Inc.
Location: Carlisle
Posted on: October 5, 2024
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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).
Keywords: Sun Pharmaceutical Industries, Inc., Lawrence , Process Engineer, Engineering , Carlisle, Massachusetts
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