Packaging Setup Operator

About the role

The Packaging Setup Operator plays a crucial role in the manufacturing of pharmaceutical products. They are responsible for setting up and operating packaging equipment, monitoring the equipment during batch operations, and ensuring quality and safety standards are met. Additionally, they are tasked with cleaning and sanitizing production areas and equipment, and accurately documenting all processes.

Responsibilities

• Setup and monitor packaging equipment within validated parameters while performing inspections, verifying components, packaging acceptable units, and maintaining required production documentation.
• Perform routine line setup, changeovers, and equipment adjustments to support scheduled packaging runs.
• Accurately record all downtimes in the GPS systems in real time in support of production tracking.
• Clean and sanitize production areas and equipment in accordance with established procedures and safety standards.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.).
• Accurately complete all documentation, including batch records and logbooks, in compliance with cGMP and data integrity requirements.
• Ensure high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Promptly report and assist in investigation of any contamination events or exceptions.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Perform other duties as assigned by management.

Requirements

• High School Diploma, GED, or equivalent required.
• 2-4 years pharmaceutical experience as a Production Operator or Setup Operator in a controlled pharmaceutical manufacturing environment preferred.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Knowledge of basic computer skills and Microsoft Office.

Physical Requirements

• Ability to stand and sit for extended periods of time.
• Must be able to continuously lift a minimum of 50 Ibs.
• Ability to operate an electric pallet jack.
• Must be physically able to wear Personal Protective Equipment (PPE).

Cognitive Requirements

• Ability to read and understand military time is required.
• Requires a high degree manual dexterity to carry out packaging activities with precision in a controlled pharmaceutical production setting.
• Strong verbal and interpersonal communication skills.
• Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
• Strong mathematical aptitude for accurate measurements and calculations.
• Mental and visual accuracy is required to produce a quality product.
• Highly skilled in problem-solving and diagnostic abilities.
• Must be able to demonstrate initiative, self-direction, and have the ability to make sound decisions.
• Demonstrates initiative and sound decision making while working effectively both independently and as part of a team.
• Demonstrates strong attention to detail in all tasks to ensure accuracy and compliance.