Cleanroom Process Technician (3rd shift 11p-7:30a)

Comar•Rancho Cucamonga, CA

8d•Onsite

About The Position

This role is for a Cleanroom Process Technician on the 3rd shift (11pm-7:30am), with weekend work included. The company is actively hiring for immediate openings. The technician will be responsible for operating equipment, setting up molds, establishing process parameters, and ensuring the production of quality products within validated molding processes. This includes operating injection molding machines and auxiliary equipment, performing safe and efficient tool and machine set-up, and troubleshooting quality/part issues. The role also involves performing product inspections, working flexible shifts and overtime, and leading project work for process improvements, Design of Experiments (DOE), and CAPA problem resolution. For SQF Certified Sites, additional responsibilities include understanding cGMPs, Good Hygiene Personnel Practices, performing basic sanitation, and identifying/reporting food safety and quality issues. The technician must adhere to all plant Health, Safety, and Quality guidelines and GMP.

Requirements

High School or Vo-Tech School graduate and 3+ years of experience as a manufacturing process technician and/or related training and experience in mold development.
Working knowledge and understanding of the molding process, injection mold tooling, and RJG cavity pressure monitoring systems.
Thorough understanding of scientific molding principles, and IQ-OQ-PQ validation process.
RJG certified
Self-motivated, conscientious, with a results-oriented mindset.
Good time management, organizational and communication skills to work independently and also in a team environment.
Ability to read and follow verbal and written instructions; write simple correspondence.
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.
Effectively communicate with supervisor.
The ability to read, write, and comprehend information provided.
Stand for most of the work shift.
Use hands and fingers to handle or feel; reach with hands and arms; stoop, crouch, bend, twist, and only occasionally sit.
Lift and/or move up to 10 pounds. Heavier amounts can be moved with assistance of equipment.

Nice To Haves

Knowledge of DELMIAWorks (formerly IQMS) Manufacturing software.
Prior work experience in an ISO 90001/13485 environment.
Experience in both Injection and extrusion molding equipment and production processes.

Responsibilities

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.
Operate 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.
Troubleshoot 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.
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.
Troubleshoot production molds and assist Production as needed.
Establish Master Cycle Cards for legacy molds.
Provide input on tool design at tool design meetings.
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.
Other duties as assigned.
Have a basic understanding of the cGMPs and Good Hygiene Personnel Practices.
Notify SQF Practitioner and/or Supervisor of any repairs or adjustments that are required.
Perform Basic Sanitation Functions.
Perform all duties necessary to meet Company, and or Regulatory Requirements / standards as prioritized by the Company, HACCP, and SQF.
Notify SQF Practitioner/Quality Manager or any other Management personnel of ANY Food Safety or Quality issues.
Identify problems relating to Food Safety and the Quality of the raw material, processes, quality system, or safety system, by performing Production/Quality Checks as assigned.
Initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system.
Execute and follow the HOLD SOP.
Control further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.
Follow all Food Fraud/food Defense Policies while on company property.
Thorough understanding of all Company policies, including GMP’s and safety policies, HACCP & SQF.
Adhere to safety policies.
Maintain a clean and safe work area and report any unsafe conditions to supervisor.
Wear company issued personal protective equipment (PPE) such as uniforms, gloves, hairnets.