Formulation​/Manufacturing Technician

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.

1. Production

a. Manufacturing & Packaging:
Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces

b. Formulation: chemical weighing and reagent formulation

c. Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs

2. Quality

a. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner

b. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations

c. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.

d. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns

e. Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

3. Safety

a. Comply with all safety policies and procedures at all times

b. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

4. Other Duties

a. Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making

b. 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

c. Perform computer applications

d. 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

i. Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.

ii. 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.

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