Bioworks Certification Jobs in Raleigh, NC (NOW HIRING)

The Manufacturing Technician position is responsible for the operation of high-speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner.

Responsibilities:

• 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 tasks.
• AQL inspections, reworks and material reconciliation that goes along with the batch.

• 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.
• 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.
• Perform self-audit of rooms and processes.
• Train and certify teammates on production processes and procedures.
• Generate reports, charts and KPIs and interpret the data to identify problems, and proceed with proper decision making.
• Work with other departments and 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 including learning and execution of SAP transactions.
• Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all customer requirements.
• Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.
• Execute tasks accurately and efficiently to meet customer expectations and maintain business continuity. Any disruptions in workflow directly impact production targets, affecting customer satisfaction and the company's financial health.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

• Minimum of 1 year of relevant experience in a regulated production/operations environment, OR equivalent military experience.
• Demonstrated proficiency in the operation of high speed, highly automated production equipment 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.

• High School Diploma, GED or equivalent.
• Certification in a BioWorks Program or equivalent preferred.
• BioWorks, LEAN or other Continuous Improvement Certificate preferred.

• Detail orientation to complete tasks without errors and produce high-quality work.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Informing others by sharing clear, timely information to ensure alignment.
• Easily accessible and open to communication.
• Consistently uphold and reflect the core ethical principles and values that bioMerieux promotes.
• Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

• Ability to remain in a stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.

• Domestic travel required: 0%
• International travel required: 0%

• May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away.
• May be exposed to Chemical Hazards 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 attire which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.
• Ability to work extended and/or overtime hours as required to support production operations.
• The job requires working 12-hour shifts which will include working on weekends and may include working overnight.
• The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping/falling hazards.
• Must be able to push/pull objects up to 150 lbs.

Manufacturing Production - Management 1

• Direct reports: 0
• Indirect reports: 0