We are seeking a dedicated and detail-oriented 3rd Shift GMP Equipment Monitoring Technician to join our team. In this critical role, you will oversee, gather, and consolidate manufacturing data from various sources, including production equipment, quality control systems, and laboratory instruments. Your primary focus will be on generating regular reports on equipment performance, maintenance activities, and addressing any issues encountered. As our organization continues to grow, your responsi... more details
Kelly Science & Clinical is seeking a GMP Equipment Monitoring Technician near Grove City, OH
Direct Hire
Shift: 3rd Shift 10pm- 6am Monday – Friday
Compensation: $50,000-$55,000
Position Summary: We are seeking a dedicated and detail-oriented 3rd Shift GMP Equipment Monitoring Technician to join our team. In this critical role, you will oversee, gather, and consolidate manufacturing data from various sources, including production equipment, quality control systems, and laboratory instruments. Your primary focus will be on generating regular reports on equipment performance, maintenance activities, and addressing any issues encountered.
As our organization continues to grow, your responsibilities will evolve, offering opportunities for professional development and advancement. You will collaborate with cross-functional teams (Process Development, Quality, Facilities & Engineering) to identify opportunities for improving equipment performance and maintenance processes, and implement best practices and innovative solutions. Your commitment to ensuring equipment is operated and maintained in a manner that promotes a safe working environment is essential.
Key Responsibilities:
- Continuously monitor GMP (Good Manufacturing Practice) and QC (Quality Control) equipment to ensure proper functionality.
- Perform regular maintenance and calibration of equipment to maintain accuracy and compliance with regulatory standards.
- Accurately record equipment performance data and maintenance activities in logbooks.
- Maintain detailed records and documentation for audit and compliance purposes.
- Diagnose and troubleshoot equipment issues promptly to minimize downtime.
- Conduct or coordinate necessary repairs and replacements of faulty components in collaboration with F&E through Blue Mountain Regulatory Assets Management software.
- Ensure all equipment monitoring and maintenance activities comply with GMP, QC, and regulatory requirements.
- Update regulatory changes and implement necessary adjustments to equipment monitoring protocols.
- Document calibration and validation processes and outcomes as per regulatory standards.
- Monitor environmental conditions (e.g., temperature, humidity) in manufacturing and QC areas.
- Assist QC teams with equipment setup and operation for testing and analysis.
- Ensure GMP/QC equipment is properly maintained and ready for use.
- Develop and execute preventive maintenance schedules for GMP and QC equipment.
- Proactively identify potential issues and address them before they impact operations.
- Maintain inventory of spare parts and consumables required for equipment maintenance and repairs.
- Ensure timely reordering of supplies to avoid interruptions in operations.
Qualifications:
- High School diploma or 1 year experience in a relevant field.
- Ability to work flexible hours, including off-shift times between 6pm and 6am, based on GMP production run schedules.
- Previous experience in equipment monitoring in a GMP, QC, or other regulated environments.
- Proficiency in troubleshooting and repairing complex equipment.
- Strong organizational and time-management abilities.
- Excellent communication and collaboration skills.
- Familiarity with regulatory requirements for data management in a manufacturing environment specific for equipment (BMRAM) is a plus.
- Understanding of manufacturing processes in the biotech industry is a plus.
Work Environment and Physical Demands: This position operates in both a laboratory and typical office environment where physical work demands will vary depending on specific tasks. The employee will be stationary (standing/sitting) for extended periods. Personal protective equipment is regularly worn based on the task. Must be able to work in confined spaces, such as clean rooms or laboratory environments. The ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area is essential.
Why Join Us:
- Be part of a dynamic team in a growing organization.
- Opportunities for professional growth and development.
- Competitive salary and benefits package.
- Work in a collaborative and innovative environment.
If you are a motivated individual with a keen eye for detail and a passion for ensuring the highest standards of equipment performance in a regulated manufacturing environment, we invite you to apply for this exciting opportunity.
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