Packaging Tech 2-Day Shift

Description

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.

Responsibilities:

1. 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.

2. 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:

1. Production

1. Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces

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

2. Quality

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

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

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

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

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

6. Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.

7. Perform self-audit of rooms and processes

8. Train and certify teammates on production processes and procedures

3. Safety

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

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

4. Other Duties

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

2. Work with other departments and 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

3. Attention to detail and the ability to accurately interpret technical documentation are critical

4. Perform computer applications including learning and execution of SAP transactions

5. Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements

6. Other duties as assigned by manager

5. Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.

6. Executing tasks accurately and efficiently is fundamental to meeting customer expectations and maintaining business continuity. Any disruptions in workflow directly impact production targets, affecting customer satisfaction and, ultimately, the company’s financial health.

Education, skills and experience:

1. High School Diploma or GED and minimum of 2 years of relevant experience in a regulated production/operations environment, OR Equivalent military experience, OR

2. BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate’s Degree with 1 year of relevant experience in a regulated production/operations environment

3. Certification in a Bioworks Program or equivalent is preferred

4. Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.

5. Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.

6. Knowledge of FDA and/or GMP regulations preferred.

7. Mechanical background preferred.

8. Ability to rapidly learn new procedures and reduce them to practice.

9. Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

10. Demonstrated experience of working independently

11. Attention to detail and the ability to accurately interpret technical documentation

Ability to operate motorized pallet jacks or forklift.

1. Performs all job functions and responsibilities in a safe and responsible manner.

2. Excellent personal hygiene required.

3. Reasonable, reliable attendance and punctuality is an essential job function required for this position.

4. Ability to remain to stand for long periods of time

5. Lifting, pushing, and pulling may be required for stocking and movement of equipment.

6. May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away

7. May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.

8. May be exposed to strong odors incurred during media production or other operations.

9. Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.

10. Ability to work extended and/or overtime hours as required to support production operations

11. The job requires working 12-hour shifts which will include working on weekends and may include working overnight.

12. The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.

13. Must be able to push/pull objects up to 150lbs