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
Support 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
Support 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 Drivers 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
The presently-anticipated base compensation pay range for this position is $79,000 to $87,500.
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus Plan.
Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.