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Manufacturing Systems Engineer Associate
2 months ago
Position Overview:
Work Environment: Fully Onsite
Initial Shift: 6:30 AM - 3 PM for the first few months, transitioning to 6 PM - 6 AM.
This role will initially follow a first shift schedule (Monday to Friday, approximately 6:30 AM to 3 PM) and will later shift to an off-hours schedule (6 PM - 6 AM). As operations commence, the selected candidate will be expected to integrate into a shift team structure to ensure coverage for the company's 24-hour operations.
Essential Qualifications:
- Experience with PLCs
- Proficiency in Electrical Troubleshooting
- Capability in Technical Writing
Safety Orientation is Mandatory
Role Summary:
Located in New Albany, Ohio, this position is part of a cutting-edge product assembly and packaging facility. The incumbent will deliver technical engineering assistance on system and equipment optimization strategies, upgrades, replacements, and modifications. Responsibilities include ensuring that utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems adhere to all relevant industry standards, regulatory requirements, and FDA guidelines within the Inspection and Packaging domain.
The initial work schedule will be administrative (Monday to Friday, approximately 8 AM to 5 PM) before transitioning to a second shift schedule. As the facility becomes operational, the successful candidate will be expected to participate in a shift team structure to support the company's 24-hour operations. This shift structure offers an excellent opportunity to accommodate individual work/life balance in non-standard shifts.
Key Responsibilities:
- Coordinate technical support on engineering, regulatory compliance, calibration, quality assurance, microbial/environmental standards, technical cleaning, validation, electrical, and process automation issues.
- Assist during inspections by regulatory agencies, providing technical support in response to inquiries from the FDA and other regulatory bodies.
- Execute advanced maintenance tasks or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and company policies. Investigate complex issues with guidance from experienced personnel.
- Help maintain an up-to-date spare parts inventory system for the equipment and systems managed by the team.
- Review and enhance current maintenance procedures to optimize the maintenance program, troubleshoot, and repair equipment/system failures.
- Interpret and analyze utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&IDs.
- Support operations during non-standard shifts, including weekends and holidays as required by business needs.
Basic Qualifications:
- High school diploma/GED with 6 years of Technical Engineering experience OR
- Associate's degree with 4 years of Technical Engineering experience OR
- Bachelor's degree in a relevant field.
Preferred Qualifications:
- Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering, or Electrical Engineering.
- Familiarity with PLCs, Computer Serialization, Packaging Equipment, and Inspection Systems.
- Experience with SCADA/PLC Control Systems in the Pharmaceutical, Medical Device, or Biotechnology sectors.
- Knowledge of other Automated Control Systems, including Siemens and Rockwell HMIs, Cognex Vision Systems, Sensors, and Systech Serialization.
- Experience with automation system hardware and software support, including installation.
- Strong organizational, project management, problem-solving, and technical writing skills.
- Excellent verbal and written communication, collaboration, influencing, and facilitation skills.
- Proficiency in MS Office applications: Word, Excel, PowerPoint.
