Job Description

Position Description:

2nd Shift: 4:00 pm to 12:00 am

Under the direction of a Maintenance Coach, provide maintenance support to pharmaceutical process equipment.

• Takes appropriate action to correct operational maintenance problems.
• Responsible for carrying out our Manufacturing 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.
• 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.

• Set-up, changes over, and adjusts all pharmaceutical production/process equipment according to current SOP's and Competency Based Training Modules. Performs experimental set-ups and runs trials of new set-ups as required. Record information after initial test runs for future routine set-ups.
• Determines proper settings and clearances, installs parts and adjusts for given machine requirements at the time of initial set-up and during operations to accommodate various sizes and shapes of tablets, bottles, packages, fill volumes, etc., as outlines in set-up specifications or as required to secure adequate productivity.
• 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 machine fabrications. 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.
• 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. This would include electrical or electronic repairs.
• Performs minor and major overhauls to process equipment by completely disassembling, repairing, and reassembling equipment to proper operation condition. This includes but not limited to disassembling Manufacturing & packaging machines & plant engineering process equipment.
• Provides technical guidance to outside contractors or servicemen, as required when they are performing work on process support equipment.
• Calibrates industrial control, measurement, and recording equipment. Prepares accurate GMP acceptable documentation recording measured information for files retention.
• Performs preventative maintenance inspections and prepares inspection reports concerning operation of equipment and mechanical condition of equipment.
• Maintains positive interaction and teamwork with other maintenance mechanics as well as Operators, Engineers, and other local and remote Manufacturing Division plant site personnel.
• Adheres to all Current Good Manufacturing Practices (CGMP) and quality procedures.
• Maintains good housekeeping in the work area.
• Consistently demonstrates ability to troubleshoot equipment. This includes patient analysis of equipment problems and perseverance in applying a solution.
• Must be able to participate in and/or provide direct specialized training to any Manufacturing Division employee requiring it.
• Fabricates machine and other parts by selecting raw materials and through the use of machine shop equipment.
• Repairs and fabricates metal parts and items using inert gas purge welding techniques. Performs soldering and arc welding. Completes jobs using deburring, buffing, and polishing equipment.
• Studies Equipment and improves operation through design and redesign of electrical, mechanical, pneumatic, and hydraulic systems.
• Interprets process controller programming, design changes, rewrites, modifies, implements, documents, verifies, records, and tests for accuracy.
• Upgrades and prepares drawings, schematics, and diagrams.
• Prepares and performs technical writing of numerous technical documents such as calibration instructions and preventive maintenance procedures.
• Performs rigging and millwright functions in the receipt and installation of new equipment.
• Uses technical information, reads and interprets drawings, diagrams, and schematics, and carries out maintenance troubleshooting and repairs.
• Participates in new equipment installations by interfacing with equipment vendors, recommending spare parts, selecting lubrication, assisting process-project engineers, effecting validation and qualification testing, performing initial de-bug and redesign operations to make equipment operable.
• Responsible for performing assignments in conformance with appropriate Regulatory (GMP's) and department standard operating procedures which assure the quality of our products.
• Responsible for performing work in a safe manner following identified safety procedures and using applicable safety equipment.

• High School diploma or equivalent and 5 years of industrial maintenance experience; or
• 2-year technical degree with 3 years of maintenance experience.