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

+ Electricians 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

The presently-anticipated base compensation pay range for this position is $79,000 to $87,500. Actual base…