GMP Facilities Mechanic (Onsite-Bridgewater, NJ)

Responsibilities

• Perform routine maintenance and troubleshooting and other process equipment in a cell therapy manufacturing facility in a Good Manufacturing Practice (GMP) environment
• Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
• Perform equipment calibrations and support validation testing to meet quality and regulatory requirements
• Respond promptly to equipment failures and implement corrective actions to minimize downtime
• Provide on-call support as required
• Execute preventative maintenance activities to ensure optimal functionality of manufacturing equipment
• Support installing and qualifying new equipment, ensuring adherence to GMP guidelines
• Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized Maintenance Management System (CMMS)
• Execute alarm response and proficiency in Building Maintenance Systems and Environmental Monitoring Systems
• Manage parts, order, and coordinate with equipment vendors and area owners to schedule maintenance activities
• Maintain tools and test equipment and ensure they are properly calibrated and in good safe working condition
• Collaborate with manufacturing and quality control teams to address technical issues and optimize processes
• Support Quality Change Controls and CAPA investigations
• Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
• Participate in training programs to enhance technical skills and knowledge

Requirements

• Associate degree or equivalent in engineering or a related field with five plus years of experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
• Strong understanding of GMP regulations and quality standards
• Proficient in troubleshooting and repairing complex manufacturing equipment
• Adequate understanding of reading and understanding technical documents and engineering drawings
• Excellent organizational and documentation skills
• Able to work collaboratively in a team-oriented environment
• Effective communication skills to interact with diverse stakeholders
• Detail-oriented with a commitment to maintaining high-quality standards
• Able to lift and carry up to 50 lbs.