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Formulation/Manufacturing Technician 1st
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Ref No.: |
23-24153 |
Location: |
Durham, North Carolina
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Position Type: | Contract |
Start Date / End Date: | 04/03/2023 to 10/06/2023 |
Manufacturing Technician/Filling Operator - Formulation
Duration: 6+ months with possibility of Extension
Location: Durham NC-27712
Shift: Standard 1 st shift
Job Description
Filling Operator - Formulation
- 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.
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
- Always comply with all safety policies and procedures.
- 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
- Minimum of 0-1 years in a regulated production/operations environment
Skills:
- Certification in Bio works 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.
Requirements:
- High School diploma or GED equivalent is required.
- 1-2 years' experience in FDA regulated manufacturing environment and (GMP) Good Manufacturing Practices is desired.
- Ability to express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications.
- Ability to perform necessary calculations and complex task sequences in order to meet production requirements.
- Attention to detail and the ability to accurately interpret technical documentation are critical.
- Ability to perform computer applications including learning and performing SAP transactions.
- Ability to routinely lift 20-40 pounds.
- Ability to stand for 8-12 hours.
- Ability to work overtime as required to cover a 24/7 operation.
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