Job Description

Description

Position Summary:  The Maintenance Technician II will troubleshoot various machines to run successfully at the validated parameters with minimal scrap and downtime to produce quality products that meet all FDA, GMP, ISO, SAP, and customer requirements. They will be responsible for moving, assembling, testing, starting, operating, adjusting, and monitoring of several production lines in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Technicians must be able to read and interpret BOM notes to setup production equipment and to perform basic preventative machine maintenance and troubleshooting on various production lines.

Essential Duties and Responsibilities:

•  Assembles and sets up a variety of production machines on different production lines.

•  Perform changeovers and adjustments to bring machines to optimal production conditions
•  Ability to work accurately and timely to meet the necessary goals for production
•  Anticipates needed equipment, parts, and supplies for production lines
•  Understands the process flow and step-by-step requirements for manufacturing 
•  Understands quality requirements for all finished good items.
•  Adjusts settings such as pressures, temperatures, weights, dimensions, tension, depth, and speeds to meet the validated requirements that are established by the quality department to produce product.
•  Performs preventative maintenance on equipment.
•  Is able to read gauges, dials, displays and monitors to ensure that machinery is functioning properly.
•  Makes minor repairs throughout the plant when requested.
•  Qualified Technician is capable of working with standard machine shop tools and equipment such as lathes, mills, drills, grinders, punches, welders, and variety of power tools.
• Setup production equipment by reading and interpreting BOM notes
•  Diagnoses equipment problems and establishes a plan to repair it.
•  Notifies Supervisor/Manager concerning need for major repairs or additions to lighting, heating, and ventilating equipment.
•  Submits orders for parts to repair equipment and maintains an inventory of “wear and tear” parts as that are consumed from inventory.
•  Technical comprehension of mechanical functions and controls for filling equipment.
•  Able to assist in training on equipment
•  Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level 
•  Identifies options for equipment use or purchase.
•  Assists with new equipment IQ/OQ/PQ. 
•  Comply with current SOP’s and GMP’s
•  Maintain housekeeping in conformance with cGMP’s.
• Perform other duties and assignments as instructed by the Supervisor/Manager.

Qualifications

Skill and Qualifications:

• High school diploma or GED
• Minimum of 5 years of experience in a contract manufacturing environment or equivalent industrial setting
• Ability to read, write, and interpret technical documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Effective written and verbal communication skills, including the ability to document routine reports and correspondence clearly and concisely
• Strong mathematical skills, including the ability to perform basic arithmetic operations (addition, subtraction, multiplication, division)
• Ability to measure, calculate ratios, and interpret graphs and chart
• Problem-solving skills and the ability to apply critical thinking to resolve issues
• Ability to follow written and verbal instructions, as well as diagrams and blueprints

***Please note that all candidates must successfully pass a background check and a 10-panel drug screening before being considered for employment. ***

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform 'the essential functions’ of this job.

The employee must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds. While performing the duties of this Job I the employee is regularly required to use hands to finger! handle or feel and reach with hands and arms. The employee is frequently required to stand, sit, and climb or balance. The employee is occasionally required to walk; stoop kneel, crouch, or crawl; talk or hear and taste or smell. The worker is required to have visual acuity to determine the accuracy, neatness, thoroughness of work assigned (i.e., custodial, food services, general labor, etc.}.

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.