Manufacturing Systems Engineer
1 week ago
We are seeking a highly skilled Manufacturing Systems Engineer to join our team at BioSpace, Inc. in New Albany, Ohio. As a key member of our operations team, you will be responsible for providing technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications.
Key Responsibilities- Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards, and FDA standards in the Inspection and Packaging area.
- Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.
- Assist during regulatory agency inspections and provide technical support in response to the FDA and other regulatory agencies.
- Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and Amgen policies.
- Investigate complex issues or problems through the mentorship of experienced staff.
- Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
- Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, troubleshoot, and repair equipment/system failures.
- Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&IDs.
- Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
- Bachelor's degree or equivalent in a relevant field.
- Or Associate's degree and 4 years of Technical Engineering experience.
- Or High school diploma/GED and 6 years of Technical Engineering experience.
- Preferred qualifications include educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering, or Electrical Engineering.
- Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System, SCADA/PLC Control System experience in Pharmaceutical, Medical Device, or Biotechnology Industry.
- Other Automated Control Systems to be supported are: Siemens and Rockwell HMIs, Cognex Vision System, Sensor, and Systech Serialization.
- Experience with automation system hardware and software support, including installation.
- Excellent organizational, project management, problem-solving, and technical writing capability.
- Strong communication: verbal/written, collaboration, influencing, and facilitation.
- MS Office: Word, Excel, PowerPoint.
We offer a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
Stock-based long-term incentives.
Award-winning time-off plans and bi-annual company-wide shutdowns.
Flexible work models, including remote work arrangements, where possible.
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