Process Technician IV

Comar•West Bend, WI

11d

About The Position

Essential Functions ( other duties may be assigned ) Be able to effectively operate equipment as required. Set up molds and establish process parameters in various molding machines using established documentation, tools, quality and production concepts in accordance with established safety procedures. Responsible for starting up machines to produce quality product within validated molding processes. Operates Injection molding machines and auxiliary equipment to manufacture product which conforms to quality specifications, at the rated output. Perform and maintain safe and efficient tool and machine set-up, operation, and process capabilities to meet customer on-time delivery and quality expectations. Perform startups including completion of all required quality management system documentation. For end- to-end molding through secondary packaging equipment - troubleshoots quality/part issues by confirming plastic conditions and performing root cause analysis to determine true root cause solutions. Verify process parameters prior to start up and assure process is running to validated parameters. Identify machine problems and communicate to maintenance as required. Resolve basic mold issues and/or secondary packing equipment issues. Work with other molding team members to keep equipment running during breaks and callouts. Perform thorough product inspections and make appropriate decisions relative to product quality requirements. Work flexible shifts and overtime as needed and maintain reliable attendance. Lead project work for process improvements, Design of Experiments (DOE), and/or CAPA problem resolution for process development as well as systems and new products, customers, processes or equipment. Develop molds capable of running repeatable and robust molding processes by collaboratively working with Engineering, Quality, and Production teams. Employ and document process development procedures based on scientific molding principles, applicable Design of Experiments (DOE’s) and RJG technology. Ensure that the development history of molds is documented and forward to Document Control. Work with project engineers and tool room to inspect and benchmark molds in the tool room prior to beginning process development. Help refine and continuously improve process development capability and mold validation process. Develop ideal nominal processes while achieving or exceeding quoted cycle times, including Robot programming. Perform 1 st shot on new tools & auxiliary equipment. Trouble shoot production molds and assist Production as needed. Establish Master Cycle Cards for legacy molds. Provide input on tool design at tool design meetings. Can execute, problem solve, re-design or improve process development of all injection or extrusion molds. Works effectively with Engineering, Quality, and Production teams to develop molds capable of running highly repeatable and robust molding processes. Effectively applies science-based process development procedure and validation protocol. Work with Quality, Engineering, and Production to improve overall mold development and validation. Effectively onboard, train, coach and develop Production Operators, Set Up Mechanics and Process Technicians. Maintain required process documentation. Maintain a clean and safe work environment. Adhere to and communicate to others all plant Health, Safety and Quality guidelines and GMP. Lead maintenance technicians on troubleshooting IMEBM Presses & Auxiliary equipment. Order components as needed using IQMS. Travel as needed for tool qualifications. Other duties as assigned. EDUCATION & EXPERIENCE High school diploma or equivalent required. RJG certified 5+ years related experience as a manufacturing process technician and/or related training and experience in mold development. Proficient with the production molding process, injection or extrusion mold tooling, and RJG cavity pressure monitoring systems. Thorough understanding of scientific molding principles, and IQ-OQ-PQ validation process. Thorough knowledge and understanding of the molding process, scientific molding principles, RJG cavity pressure monitoring systems, and eDART™ cycle graph interpretation. Thorough understanding of injection or extrusion mold tooling and the IQ/OQ/PQ validation process.

Requirements

High school diploma or equivalent required
RJG certified
5+ years related experience as a manufacturing process technician and/or related training and experience in mold development
Proficient with the production molding process, injection or extrusion mold tooling, and RJG cavity pressure monitoring systems
Thorough understanding of scientific molding principles, and IQ-OQ-PQ validation process
Thorough knowledge and understanding of the molding process, scientific molding principles, RJG cavity pressure monitoring systems, and eDART™ cycle graph interpretation
Thorough understanding of injection or extrusion mold tooling and the IQ/OQ/PQ validation process
Ability to read and follow verbal and written instructions; write simple correspondence
Effectively communicate with supervisor
Proficient with computers – Can log in to IQ and accurately enter production data and complete production forms (batch record)
Basic math skills - add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, percentages and decimals
Ability to use measuring devices such as Comparator, Dial indicator, Go/No Go gauges
Use Quality Control instruments such as calipers, gram scales and magna mike
Ability to work in a fast-paced manufacturing environment with demonstrated ability to handle and prioritize multiple tasks and demands
Strong technical aptitude, as well as analytical and problem-solving skills
Sound judgment - ability to work efficiently with many competing demands
Act as a role model for all plant Health, Safety and Quality guidelines and GMP
Ability to lead projects and teams of people for process improvements, DOE or CAPA problem resolution
Ability to work effectively across functions to achieve results
Ability to author documentation for process improvement, DOE or CAPA
Ability to easily adjust plans between projects and troubleshooting production molds and assisting Production as needed
Effectively present process improvement and problem resolution solutions in one-on-one and small group situations to customers, clients, and other employees of the organization
Can effectively onboard, train, coach and develop Production Operators, Set Up Mechanics and Process Technicians
Ability to prioritize, plan, organize and coordinate work across Process Technicians I, II, III
Ability to lead the process technician team in absence of management

Nice To Haves

Master Molder 1 certificate desired
Experience in both injection and extrusion molding equipment and production processes
Previous experience in related functions and an ISO 9001/13485 environment
Knowledge of IQMS
Self-motivated, conscientious, with a results-oriented mindset
Good time management, organizational and communication skills to work independently and also in a team environment
The ability to read, write, and comprehend information provided to them
Work flexible shifts and overtime as needed and maintain reliable attendance

Responsibilities

Effectively operate equipment as required
Set up molds and establish process parameters in various molding machines
Start up machines to produce quality product within validated molding processes
Operate Injection molding machines and auxiliary equipment
Perform and maintain safe and efficient tool and machine set-up
Troubleshoot quality/part issues
Verify process parameters prior to start up
Identify machine problems and communicate to maintenance
Resolve basic mold issues and/or secondary packing equipment issues
Perform thorough product inspections
Lead project work for process improvements
Develop molds capable of running repeatable and robust molding processes
Employ and document process development procedures based on scientific molding principles
Work with project engineers and tool room to inspect and benchmark molds
Develop ideal nominal processes while achieving or exceeding quoted cycle times, including Robot programming
Troubleshoot production molds and assist Production as needed
Establish Master Cycle Cards for legacy molds
Provide input on tool design at tool design meetings
Execute, problem solve, re-design or improve process development of all injection or extrusion molds
Effectively apply science-based process development procedure and validation protocol
Effectively onboard, train, coach and develop Production Operators, Set Up Mechanics and Process Technicians
Maintain required process documentation
Maintain a clean and safe work environment
Adhere to and communicate to others all plant Health, Safety and Quality guidelines and GMP
Lead maintenance technicians on troubleshooting IMEBM Presses & Auxiliary equipment
Order components as needed using IQMS
Travel as needed for tool qualifications