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Formulation/Manufacturing Technician 1st
Ref No.: 23-24153
Location: Durham, North Carolina
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.