Associate Technician, Maintenance

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

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