Manufacturing Technician 1, Line 4 - Night Shift
Job Summary
Job Description
The Manufacturing Technician is responsible for operating high-speed equipment in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. This role involves performing and assisting with equipment setup, inspection, preventive maintenance, troubleshooting, and cleaning. The technician will complete production batches and associated documentation, ensuring adherence to Manufacturing Directions and SOPs. Key responsibilities include operating automated production equipment, maintaining quality standards through accurate batch paperwork and process documentation, assisting with deviation analysis and CAPA actions, and maintaining clean work areas. The role also requires compliance with safety policies and procedures, including proper use of Personal Protective Equipment. Additionally, the technician will generate reports, assist with validation protocols, and perform computer applications.
Must have:
- Operate high speed manufacturing equipment
- Execute production activities per approved Manufacturing Directions
- Ensure batch paperwork is completed accurately and timely
- Comply with all safety policies and procedures
- Use appropriate PPE
Good to have:
- Certification in a Bioworks Program or equivalent
- Proficiency in operating high speed, highly automated production equipment
- Knowledge of OSHA regulations (LOTO, electrical safety)
- Knowledge of FDA and/or GMP regulations
- Mechanical background
Perks:
- Low-cost medical, dental, and vision benefits
- 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
3 skills required
Job Details
Description
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
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 & Responsibilities:
Normal working hours: 7:00pm - 7:30am working a 2-2-3 rotation schedule.
Normal working hours: 7:00pm - 7:30am working a 2-2-3 rotation schedule.
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. 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.
- Production
- 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
- 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
Experience, Skills and Education:
- High School Diploma/GED with 0+ years of relevant experience in a regulated production/operations environment
- Certification in a Bioworks Program or equivalent is preferred
- 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.
- Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer
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