Operator 3, Machine

JOB DESCRIPTION
Performs routine set up, operation, minor and major routine maintenance, preventative maintenance (PM) and troubleshooting of highly complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Must possess mechanical aptitude to complete changeover of equipment and some operator level preventive maintenance. Assist with root-cause analysis activities for process or product exceptions. Checks work using prescribed gauges, jig and fixtures to measure close tolerances. Monitors and verifies quality in accordance with statistical process or other control procedures. Ensures accurate documentation of all relevant quality, safety and maintenance documents. Identifies, troubleshoots, and resolves complex issues associated with the machine performance and/or product quality.

Responsibilities and Duties

o Works within standards and operating procedures to plan, perform, and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting

o Uses independent judgment in troubleshooting and problem solving under little/no supervision

o May perform clean up functions in sterilized areas

o Identifies the need for minor equipment repairs

o Analyze and evaluate charts, follows simple diagrams, testing, and inspecting procedures

o Conducts root-cause analysis activities for process or product exceptions

o May monitor quality in accordance with statistical process or other control procedures.

o Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves complex issues associated with the machine performance and/or product quality.

o Provides support to the lead/supervisor when necessary

o May provide training support for on-boarding and/or new procedures

o May provide support on special projects

o Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)

o Must follow all Client housekeeping policies and procedures

o Must follow all Client safety policies and procedures

o Must be able to work overtime as required to meet Client business requirements

o Perform other duties as required

Qualifications

Minimum Education/Experience:

o High School degree with 4 years manufacturing experience including Food, Pharma, and Industrial production settings. Must have experience working in a regulated environment (FDA).

o AA technical degree with 2 years experience

Basic Skills:

o Can effectively work in a team setting and communicate effectively across the department

o Strong attention to detail

o Ability to be punctual in order to ensure production

• Ability to work on assignments that are semi-routine in nature with the skill to recognize any deviations from specification
• Ability to operate independently within the constraints of approved process-related documentation

Proficient/Working Skills:

o Must be proficient in English with the ability to read, write, analyze/evaluate charts, follow simple diagrams and perform basic arithmetic

Must be able to work flexible and/or extended hours and report to work on a regular, punctual basis. Ability to get along with people and be able to work in a team environment. Willingness to rotate into different tasks and responsibilities.