Sr. Tech, Operations Mechanic

Job Description

Under the direction of Maintenance Coach, sets up, adjusts, repairs, and maintains all Pharmaceutical process equipment.  Performs calibrations and maintains industrial instrumentation standards.  Carries out industrial maintenance functions in accordance with current Good Manufacturing Practices and prepares technical documentation on as needed basis.  Participates in the establishment and improvement of new and existing process equipment.  Provides technical specifications and information to Research and Development, Process-Project Engineers, and other Manufacturing Division requestors.  Primary focus will involve maintaining process equipment by developing/performing PM's, developing/performing instrument calibrations, installing new equipment, completing validation protocols, documenting work using a computerized maintenance management system (CMMS - SAP) and other duties as requested by the maintenance coach.

Equipment: 

• All equipment (packaging, manufacturing, and utilities) used in the Pharmaceutical operation. 

• Diagnostic, test, and comparison standards used in industrial calibration programs. 

• Machine shop equipment: lathe, drill press, grinder, milling machine, gas and electric welder, and power cutting tools. 

• Electric programming and diagnostic equipment. 

• Precision calibrated equipment necessary for the complete maintenance of processes used in the manufacture and packaging of ethical drugs. 

• Programmable logic controller & other computer interfaced controller equipment.

DUTIES

• Basic duties of the position are listed below; however, employees are expected to perform other duties or to accept other assignments to compensate for workload shifts as the need arises.

• 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