Senior Manufacturing Support Engineer

Job Summary

Sr. Manufacturing Support Engineer support engineering & advanced troubleshooting activities for pharmaceutical manufacturing equipment and critical systems, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.

Area Of Responsibility

• Provides advanced troubleshooting, rapid recovery, On-call response, directly involved with uptime, execute approve changes, and possess deep knowledge as an SME for the following equipment:

• Isolators/vial fill line
• Lyophilizer and loader isolator
• Powder filling machine
• Automatic labelling machine
• Secondary packaging (i.e Serialization / Aggregation)
• Autoclaves
• Sterilizers
• Washers

• Support Manufacturing Engineer with retrofit and upgrade projects, but does not own projects
• Troubleshoot process equipment/sterile filling
• Ensuring smooth operations of process and filling equipment
• Develop and maintain records on pharmaceutical manufacturing equipment and systems to maintain operations and validation
• Operate production equipment for setup and or production purposes as needed
• Perform non-routine and off-hours tasks as necessary
• Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
• Supports updates or improvement on maintenance SOPs for equipment
• Follow all company policies related to job safety
• Lead troubleshooting for complex problems related to manufacturing and critical systems
• Supports Manufacturing Engineer with improvements, upgrades and enhancements of manufacturing & critical systems
• Support validation maintenance program
• Support in the development and mentor of peers
• Monitor process operations to ensure compliance with specification
• Ensure equipment operational readiness
• Provide Re-Qualification support for process equipment
• Provide equipment operational support, including being on call 24/7 (required)
• Support change controls, deviations and CAPAs, but does not own quality records
• Support Manufacturing Engineer and Validation Engineer with remediation during FAT/SAT/ IQ/OQ/PQ, but does not own the completion of this documents
• Performs advance troubleshooting applying knowledge in Mechanical, Electrical, automation and process fields.
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Shop/shipping areas
• Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

• Stand, walk, sit, 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, distance and peripheral vision; depth perception, ability to focus
• Ability to operate production equipment and hand tools
• Operate hand truck
• Operate company truck
• Current, valid Driver's license
• Operate computer/office machines
• Wear Safety shoes, safety glasses, gloves
• Lift up to 70 lbs.
• Ability to work a flexible schedule

Travel Estimate

Up to 5%

Education and Job Qualification

• BS. Mechanical Engineer preferred or equivalent
• High school diploma or equivalent required

• Technical certification preferred
• Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
• Knowledge of aseptic techniques
• Ability to read & create engineering drawings
• State boilers “Special License to Operate” or higher preferred / obtain within 6 months of employment
• Electrician’s license preferred
• Ability to plan, prioritize and organize diversified workload
• Familiarity with use of computers and MS Office

Experience

• Minimum 10+ years related experience  or BS in Engineering + 6 years or AS in STEM field + 8 years
• Experience working with electronic document systems ( CMMS work orders ,LMS, Track Wise, Master Control ) or similar systems

• Experience with Building Automation Systems
• HAZMAT training
• Formal cGMP training
• Proficient with use of hand tools and power equipment
• R.O./ D.I. water system experiences a plus