Process Engineer

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).