Associate Technician, Maintenance

Job description

Job Description Associate Technician, Maintenance Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills) Associate Technician, Maintenance (1st Shift) The Bio Process Maintenance Associate Technician will be a member of the Maintenance & Operations team within the Vaccines integrated process team for a start-up vaccine manufacturing facility in Wilson, NC.  Under the direction of a Operations/Maintenance Coach, provide maintenance support to Pharmaceutical process equipment. Takes appropriate action to correct operational maintenance problems. Responsible for carrying out the Manufacturing Division Divisional and site mission by assuring the quality of products and services are of the highest quality, optimal cost, and delivered on schedule. Responsible for continuing improvement in all aspects of the operation. In addition to the day to day maintenance activities, the individual is accountable for providing shop floor operations support to aseptic manufacturing within the vaccine manufacturing facility. Tasks will include aseptic primary filling, inspection, packaging, CIP/SIP and room and equipment disinfection.  Must be able to function in a team-based culture and operate in an empowered environment. Identifies and demonstrates a working knowledge of customers, suppliers and their requirements. Seeks ideas and information on how to improve customer service involving internal and external customers. Applies knowledge of the overall supply chain to efficiently complete work tasks. Applies knowledge of key business processes in their functional areas to perform daily work tasks. Adheres to the highest level of data integrity in all activities. Delivery Checks set-up, changes over, and adjusts production/process equipment according to current SOP’s and Competency Based Training Modules. Performs experimental set-ups and runs trials at the direction of the process/project/reliability engineer as required. Determines proper settings and clearances, installs parts and adjusts for given machine requirements at the time of initial set-up and during operations as outlined in set-up specifications or as required. Execute corrective and preventative maintenance on manufacturing equipment Test runs equipment to determine coordinated timing, alignment, machine height, and other relatively basic fixed adjustments. Disassembles and inspects parts and equipment to determine the cause of improper operations. Makes a repair through the use of replacement parts and reassembles equipment with new or repaired parts. Cleans and lubricates machines periodically and performs other maintenance work required to assure the efficient operation of all equipment. Performs minor and assists with major overhauls to process equipment by disassembling, repairing, and reassembling equipment to proper operation condition. This includes but not limited to disassembling manufacturing/Filling/Packaging machines & plant engineering process equipment. Identifies the root cause of equipment malfunctions occurring while equipment is in operation and whenever possible repairs and adjusts the equipment in a manner which will result in the minimum production delay. Assist with the the calibrate of industrial control, measurement, and recording equipment. Prepares accurate GMP acceptable documentation recording measured information for files retention. Uses technical information, reads and interprets drawings, diagrams, and schematics, and carries out maintenance troubleshooting and repairs. Set up and perform aseptic vaccine manufacturing to include primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems. Perform other duties as requested by the Operations coach Demonstrates the ability to troubleshoot equipment. Compliance Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE) Execute maintenance and operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs) Complete documentation in EAM, electronic batch records, electronic logs, and other systems in accordance with site procedure Maintain good housekeeping and 5S in assigned work area Adhere to the highest level of data integrity while performing duties Identify potential quality or safety issues.  Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation. Must be able to participate in and/or provide direct specialized training to any Manufacturing Division employee requiring it. Cost Ensure that startup activities for area of assignment are executed such that deliverables and timelines are met Closely monitor team / process performance and improve reliability through problem solving and continuous improvement Set up, troubleshoot and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards Identify and help implement continuous improvement and productivity enhancements within the IPT Team Partner with Technicians, Operations personnel and cross-functional groups for assigned area Demonstrate a high degree of maturity and personal integrity.  Strictly adhere to all site policies on personal conduct and attendance. Train, develop, and mentor other team members to share experience and best practices Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving Routinely demonstrates leadership and conflict-resolution ability.  Demonstrates a willingness to provide and receive constructive feedback in 360° performance review. Responsible for performing work in a safe manner following identified safety procedures and using applicable safety equipment. Reporting Relationships: Solid line report to: Manager, Maintenance & Operations Dotted line report to: N/A Position(s) reporting to this position: N/A (individual contributor) Work Schedule: 8-hours 1st Shift (06:00AM - 02:30PM) Minimum Education Requirement: High School diploma or equivalent Required Experience and Skills: One or more years of experience in a GMP manufacturing facility including maintenance experience (aseptic GMP environment strongly preferred). Demonstrated ability to work independently and as team member Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment Ability to gown and work in an aseptic environment Demonstrated ability to work with computerized and automated systems. Willing to work irregular hours to support multi-shift operation on an as needed basis Preferred Education, Experience and Skills: Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates, such as Bioworks, preferred. Experience with maintenance troubleshooting, Preventative and Corrective Work Orders, aseptic filling equipment, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, a