Job Description
Job Description
Job Title: Clean Room (2nd Shift)
Job Description
This role supports cleanroom production and warehouse operations on 2nd shift (3:00 pm–11:00 pm, Monday through Friday) in a highly controlled environment that manufactures products used in the pharmaceutical industry. You will weigh and fill chemicals and bulk products, operate production and packaging equipment, manage inventory and shipping activities, and maintain precise documentation in accordance with cGMP and ISO standards.
Responsibilities
- Weigh and fill chemicals and bulk products according to production work orders and established procedures.
- Package finished products, including labeling, preparing materials for shipment, and ensuring accuracy of packaging information.
- Operate and maintain production equipment such as scales, pumps, fillers, crushers, sealers, shrink-wrap machines, and other manufacturing equipment.
- Follow cleanroom gowning procedures and cGMP requirements to maintain an ISO Class 7 environment.
- Complete production documentation, batch records, ERP entries, and quality paperwork accurately and in a timely manner.
- Handle chemicals and hazardous materials while wearing required personal protective equipment, including a ventilated hood when working in the clean room and assisting with bulk filling.
- Clean and sanitize equipment, tools, and work areas throughout the shift to support a very clean and organized environment.
- Participate in continuous improvement initiatives and support team production goals by identifying opportunities to improve processes and efficiency.
- Assist with material movement and other production-related tasks as needed, including supporting bulk filling operations in the clean room.
- Store, pick, stage, and ship products, ensuring correct quantities, labeling, and documentation.
- Manage and track inventory using an ERP system, including documenting stock levels, identifying shortages, and making system adjustments during cycle counts and audits.
- Perform cycle counts and participate in inventory audits, making accurate adjustments in the computer system when required.
- Move products on cartons, pallets, and in rail car containers safely and efficiently.
- Put away stock in designated locations and document when inventory is low or when shortages occur.
- Operate shrink-wrap equipment to prepare pallets and products for shipment.
- Utilize an ERP system for documentation, tracking, and sign-off of each operation completed during down-packing activities.
- Operate filling machines in a clean room environment, ensuring adherence to ISO 9001:2015 quality standard guidelines.
- Organize the work area, stock products, and maintain a neat and efficient workspace.
- Work on your feet for the entire shift, performing frequent bending, twisting, and lifting up to 50 lbs.
- Demonstrate flexibility by helping wherever needed, including working outside the shipping department when required to support bulk filling and other production tasks.
- Maintain very accurate documentation and follow detailed procedures for products used in the pharmaceutical industry.
Essential Skills
- High School Diploma or GED required.
- Ability to lift up to 50 lbs throughout the shift and perform frequent bending, twisting, and standing for the entire shift.
- Previous experience in manufacturing, production, warehouse, or cleanroom environments preferred.
- Basic computer skills, including familiarity with Microsoft Word and Excel.
- Strong attention to detail with the ability to follow written work instructions, procedures, and quality guidelines.
- Comfort handling chemicals and hazardous materials while following safety protocols and using required PPE.
- Ability to accurately complete documentation, batch records, and ERP entries in a regulated environment.
- Experience working in a GMP-regulated environment is a plus.
- Experience as a chemical handler, batch mixer, or material handler is beneficial.
- Experience with warehouse operations and forklift use is helpful.
- Ability to operate production and packaging equipment such as fillers, pumps, scales, and shrink-wrap machines.
Additional Skills & Qualifications
- Clean room experience / chemical handler experience
- Prior use of ERP systems for documentation, inventory tracking, and production sign-offs.
- Strong organizational skills to maintain a clean, well-stocked, and efficient work area.
- Ability to work effectively as part of a team and support continuous improvement initiatives.
- Comfort with cross-functional responsibilities across production, c