US - Manufacturing Operator 1 - Lenexa

Job description

Description:
Performs production procedures in accordance with Standard Operating Procedures (SOP), resulting in quality product.
Formulation Tasks:
-Gather chemicals from different storage locations (i.e. room temperature, coolers and freezers);
-use designated weights from 1 gm to 250 kg to verify scales; scoop and dump chemicals into containers up to 1,000 kg;
-place finished containers on a scale to verify gross weights;
-use a computer to capture production information;
-approve related reports and complete related documentation.
Blending and Milling Tasks:
-Check rooms and equipment for cleanliness and damage prior to use;
-locate formulated chemicals for charging into blenders;
-setup and operate blenders in accordance with required specifications;
-setup and operate pin mill system in accordance with required specifications;
-setup and operate nitrogen conveying system; setup and operate clean-in-place (CIP) systems;
-control and monitor processes with an operator interface terminal (OIT);
-use a computer to capture production information; approve related reports and complete related documentation.

Packaging Tasks:
-Use designated weights from 1 gm to 25 kg to verify scales are in specification;
-confirm material and supplies are staged; set up and operate automated packaging equipment within specified tolerances;
-fill powder into final containers up to 100 kg in weight;
-perform label reconciliation to ensure proper package labeling; move pallets of product to finished goods storage;
-approve related reports and complete related documentation.
-Must be able to properly gown and comply with all cGMP and PPE guidelines
-Set-up equipment ensuring operations are consistent with current operating procedures. Equipment components can weigh up to 50 kg and have critical tolerance requirements.
-Report equipment failures and work with repair personnel to correct problems
-Performs procedures resulting in the cleaning of manufacturing equipment and facilities.
-Continually increases proficiency and understanding of manufacturing processes and systems.
-Able to Read and Understand all written procedures as outlined in SOPs
-Work Instructions and Master Batch Records (MBR).
-Completes all documentation in accordance with current Good Manufacturing Practices (cGMP) and SOP.
-Perform operations in compliance with rules and in a safe, orderly manner.
-Participates in training programs as directed by the Department Supervisor. This may include monthly safety meetings, internal safety audits of operations, respirator training, and skill-based pay.
-Follow production procedures and safety policies at all time.
-Maintain good housekeeping in working areas.
-Reports any unsafe working conditions or safety concerns through the corporate Medgate system.
-Reports any property damage to the shift supervisor immediately
-Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations.
-Use, clean, and store all personal protective gear appropriately
-Makes recommendations for continuous process improvements in the manufacturing area.
-Actively participates in Quality systems practices.RequirementsEducation
-High school diploma or equivalent with good math and reading skills.Experience
-Experience in a manufacturing environment preferably with cGMP or regulatory compliance practices.
-Demonstrated mechanical aptitude including previous maintenance experience with process equipment or mechanical systems.
-Dry product processing and packaging experience.

Knowledge and Skills
-Ability to read and follow written and verbal instructions.
-Ability to perform basic metric and other mathematical calculations.
-Ability to work independently and as part of a team.

Soft Skills
-Works as a productive member of a team
-Ability to effectively communicate with others.
-Basic mechanical aptitude

Basic problem solving skills Required
-Must be able to lift 5 pounds for a six hour period, or as required. Occasionally required to lift up to 50 pounds.
-Must be able to maneuver and position mechanical components up to 50 kg.
-Must be able to stand for long periods of time
-Must be able to work within a controlled space without excessive perspiration