Packaging Tech 1

Position Summary

Global Generic Summary
Packaging Operations are accountable for setting up, operating, maintaining, and troubleshooting manufacturing packaging machinery/equipment including:
Operating manufacturing packaging equipment that packages materials or products by inserting them into containers or filling containers from spouts or chutes
Monitoring, evaluating, and adjusting manufacturing packaging equipment to maximize quality and efficiency
Restocking machines with packaging materials
May include packing, wrapping, securing, or labeling containers
Responsible for changeovers of format and adjustments of tools
Performing standard operating procedures to meet current Good Manufacturing Practices (GMP) and maintaining records as required.

Local Specific Summary
The Packaging 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:
The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT 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.

Local Primary Duties
Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
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
Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
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
Perform computer applications including learning and execution of SAP transactions
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.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Qualifications

Required Education, Training and Experience
High School Diploma, GED or equivalent
No previous experience required, Some experience preferred
Relevant experience in a regulated production/operations environment, OR Equivalent military experience
Preferred Education, Training and Experience
Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.


Key Skills, Knowledge and Abilities (KSAs)
Acting with Honor and Being Open: Consistently upholds and reflects the core ethical principles and values that client promotes.
Acting with Honor and Being Open: Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.
Relating Skills: Easily accessible and open to communication
Getting Work Done Through Others: Informing others by sharing clear, timely information to ensure alignment.
Getting Organized: Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel: Basic: demonstrates fundamental awareness and can perform routine tasks with guidance
Functionally Required Knowledge, Skills, and Abilities: Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
Knowledge of FDA and/or GMP regulations preferred.
Mechanical background preferred.

Working Conditions and Physical Requirements
Ability to remain in stationary position, either sitting or standing, for prolonged periods.
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
Ability to operate heavy machinery.
Ability to adjust or move objects up to 50 pounds in all directions.

Additional Physical Requirements
May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away
May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.
May be exposed to strong odors incurred during media production or other operations.
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.
Ability to work extended and/or overtime hours as required to support production operations
The job requires working 12-hour shifts which will include working on weekends and may include working overnight.
The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.
Must be able to push/pull objects up to 150lbs

Notes:
Onsite
Day shift 7am - 3:30pm
This is a contract role with the possibility of conversion to full-time based on business needs and performance