GMP Equipment Monitoring Technician

Job Title: GMP Equipment Monitoring TechnicianJob Description As a GMP Equipment Monitoring Technician, you will oversee, gather, and consolidate manufacturing data from various sources, including production equipment, quality control systems, and laboratory instruments. This role focuses on generating regular reports on equipment performance, maintenance activities, and any issues encountered. You will collaborate with cross-functional teams to identify opportunities for improving equipment performance and maintenance processes, implementing best practices and innovative solutions. Ensuring lab equipment is operated and maintained in a manner that promotes a safe working environment is crucial. Responsibilities Continuously monitor GMP (Good Manufacturing Practice) and QC (Quality Control) equipment to ensure proper functionality. Perform regular maintenance and calibration of lab equipment to maintain accuracy and compliance with regulatory standards. Accurately record lab 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. Essential Skills 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. Additional Skills & Qualifications 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. Prior Aseptic Cleaning/Lab Sanitation Experience. Experience following SOPs. Experience gowning up and going into clean rooms highly preferred. GMP Experience is a plus. Must be comfortable fully gowning up. Work Environment This position works in both a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Shifts include 3rd shift from 10pm-6am with flexibility for overtime. Initial training will be on the 1st shift for approximately two months. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (%) for other accommodation options.

Created: 2024-11-02