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 upto $10,000 per calendar year
- Onsite cafeteria with daily food stipend
Position Summary: The Process Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle 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
- AQL inspections, reworks and Material reconciliation that goes along with the batch
Primary Duties: - Production
- Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
- Formulation: chemical weighing and reagent formulation
- 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
- 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
Knowledge, Skills, and Experience: - Education & Experience
- High School Diploma or GED Required
- Minimum of 0-1 years in a regulated production/operations environment
- Skills
- Certification in Bioworks Program preferred
- For Manufacturing and Packaging:
- Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
- For Formulation:
- Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.
- Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired.
- 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.
Job ID: 40275 Nearest Major Market: Durham Nearest Secondary Market: Raleigh