Manufacturing Tech 1/Material Handler - 3rd Shift

Normal Working Hours: Monday - Friday 10:00pm-6:30am

Benefits at bioMerieux:

• Low-cost medical, dental, and vision benefits starting day one
• 11 paid holidays
• 160 hours of paid time off
• Annual bonus
• 9.5% 401k company contribution with no vesting period
• Tuition reimbursement up to $10,000 per calendar year
• Onsite cafeteria with daily food stipend

Position Summary:

The Service Technician/Material Handler  position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and for the efficient use of the organization’s storage and distribution facilities including operation of narrow aisle reach trucks in a cGMP compliant manner.

• The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes. 
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated AQL inspections, reworks and Material reconciliation that goes along with the batch.
• Receiving supplier shipments, picking internal customer orders, shipping and inventory organization, management and control.
• Responsible for inspection, identification, and delivery to stocking locations.
• Picks and stages finished goods Stock Transfer Orders (STO’s) for loading and shipping

This position shares in responsibility of material handling activities for forty million dollars of annual inventory value.  Durham Warehosue Team process on average 5,000 inventory receipts, 2,000 picking requests, and 1000 STO’s per year.

Responsibilities:

• Production
  • Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
• Distribution
  • Pick, pack, and deliver orders for direct materials used in Manufacturing and Packaging Lines
  • Process STO’s to Distribution Center
  • Move materials to storage bins or staging areas with proper equipment following all SOPs
  • Assure quality, accuracy, and compliance with cGMP’s in shipping, receiving and the warehouse operation while maintaining a timely throughput of operations
  • Accurately receives goods, verifies items against the record of shipment, and inspects condition
  • Operate motorized and non-motorized material handling equipment in a safe manner
  • Handles and maintains flow of materials and products in manufacturing areas according to established guidelines
  • Performs all work in accordance with established safety standards and adheres to all safety policies, rules, regulations, and procedures
  • Monitors warehouse space requirements and assist with maintaining proper warehouse utilization
  • Exhibit safe work habits while maintaining a clean, neat and orderly work area
  • Other responsibilities include data entry, cycle counting, and forklift battery maintenance
  • Assess safety and environmental risks to ensure tasks adhere to HSE policies and HMS
  • Performs other duties as assigned by Management
• Quality
  • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
  • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
  • Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
  • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements
  • Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
• Safety
  • Comply with all safety policies and procedures at all times
  • Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
• Other Duties
  • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
  • Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
  • Perform computer applications
  • Perform other duties as assigned by Management

Studies and Experience:

• High School Diploma or GED
• Minimum of 0-1 years in a regulated production/operations environment
• One (1) year of warehouse and forklift experience required
• Certification in Bioworks Program preferred

Skills and Qualifications:

• For Manufacturing and Packaging
  • Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
• For Distribution
  • Knowledge of warehouse management systems (WMS) and use of RF scanners preferred.
  • Ability to safely operate Power Industrial Trucks (PIT) including narrow aisle reach trucks in all directions.
  • Knowledge of DOT, IATA, ISO preferred.
  • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
  • Knowledge of FDA and/or GMP regulations preferred.
  • Mechanical background preferred. 
  • Ability to rapidly learn new procedures and reduce them to practice.  
  • Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
  • Ability to perform basic math and data entry.
  • Good communication skills.
  • The ability to follow directions and work unsupervised.
  • Must be able to safely and effectively handle box cutters and/or similar tools.

Physical Requirements:

• Performs all job functions and responsibilities in a safe and responsible manner.
• Ability to regularly climb stairs to perform work.
• Ability to operate motorized pallet jacks.
• May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
• May be exposed to strong odors incurred during media production or other operations.
• Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.  Make-up and jewelry are prohibited in certain areas of Manufacturing.
• Ability to maintain reliable and punctual attendance
• Ability to work overtime as required to support a 24/7 production operation