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Maintenance Technician - Production

Blue Ash, Ohio
General Purpose of Position:
This position is responsible for performing and documenting, per GXP (Good “anything” Practices) practices, the maintenance and calibration activities required for Aprecia Pharmaceuticals solid dosage facility’s manufacturing and packaging equipment.

The duties include operation, maintenance, and calibration of the manufacturing and packaging systems in the facility.  Manufacturing and packaging systems also include, but are not limited to, the utility support equipment.  Assigned tasks will include preventive and corrective maintenance which include pneumatic, electrical, plumbing, and carpentry work.  Activities also include device calibrations, equipment troubleshooting, etc.

The objective of this position is to work with other OE (Operational Engineering), operations, and office personnel to ensure that products are developed and manufactured in an environment which focuses on safety, quality and effective manufacturing, packaging, and facility processes.

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Troubleshoots and repairs packaging and manufacturing equipment as required to support operations.  This includes reading and interpreting mechanical drawings and electrical schematics as needed to troubleshoot, repair and maintain the equipment
2 Performs preventive maintenance (PM) on the manufacturing and packaging equipment
3 Initiates work orders for repairs and/or adjustments to the manufacturing and packaging equipment that are performed
4 Initiates purchase requisitions for materials needed for repair, PM or consumed during the performance of their duties
5 Completes all required documentation needed to maintain the GXP requirements associated with work order completion and training records
6 Install/assist with installation and start-up of new equipment brought into the facility
7 Develop improvement ideas to increase efficiencies and/or reduce labor. Trained to provide back up support for production maintenance
8 Completes modifications to the manufacturing and packaging equipment utilizing the Change Control program
9 Executes manufacturing and packaging equipment qualification protocols
10 Assists the writing and approval of manufacturing and packaging equipment TL’s (Task List’s) and SOPs (standard operating procedures)

Reporting to this Position:
No direct reports

Travel:
Position may require 1-5% travel

Work Shift:
Responsibilities for this role may be covered across multiple shifts

Knowledge, Skills and Abilities:
  • Demonstrated expertise with troubleshooting and repair of automated servo controlled equipment and high speed packaging and manufacturing equipment
  • Strong analytical skills and working knowledge of electrical, computer, servo, pneumatic, and mechanical systems
  • Must be able to read and comprehend mechanical drawings, schematics, wiring diagrams, and technical manuals
  • 3-5 years’ experience must include programmable logic controllers (PLC), PC based control systems, and hardwired relay logic systems 
  • Metal fabrication is preferred but not required
  • Must be able to work well in a team environment and independently on tasks and projects

Education and Experience:
  • High School diploma/technical school or equivalent military experience is preferred
  • Qualified candidates should have 5-7 years of experience in a regulated industry with specific experience on troubleshooting, repair, and routine maintenance of manufacturing and packaging equipment

Physical Demands and Work Environment:    
  • Ability to stand and walk for long periods of time
  • Ability to bend, lift, carry, and manipulate materials and machine parts (1-80 lbs) to accomplish equipment repairs, installations, and maintenance. Exposure to odd body positions (i.e. twisted torso, bent over position, etc) for brief periods of time during the troubleshooting and/or repair of the equipment.
  • Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods of time.
  • Operate computer controlled equipment which requires a combination of standing, sitting and walking to and from the operator interface terminal
  • Required to work around live electrical circuits and mechanical devices in the execution of their duties
  • Exposure to odd body positions (i.e. twisted torso, bent over position, etc) for brief periods of time during the troubleshooting and/or repair of the equipment
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, steel toe shoes)

GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

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