Manufacturing Operator 1

About the role

This position is primarily focused on weekend operations, with the flexibility to support weekday training as needed. The role involves serving as an advanced-level Manufacturing Operator responsible for producing biopharmaceutical filtration devices, with a strong emphasis on safety, quality, and productivity. As a critical and adaptable team member, you are expected to quickly learn new processes and operate across multiple work centers to meet customer demand. Additionally, you will play a key role in supporting back-order recovery, loss recovery, and site training initiatives by bridging gaps in high-priority areas.

Responsibilities

• Flexing working hours between weekdays and weekends to facilitate training and production time
• Manufacture quality products safely and in accordance with Standard Operating Procedures, Quality and Safety Specifications and GMP standards.
• Safely operate a manufacturing process and monitor required inputs and outputs.
• Support proper line opening and line closing through material control and proper machine set up.
• Accurately complete documentation per GMP standards.
• Ensure a clean and orderly workspace.
• Proactive identification of safety, quality, and productivity concerns.
• Actively report hazardous conditions or hazardous behaviors observed in the work center and the site.
• Demonstrates strong operational awareness by aligning efforts with weekly site priorities, actively participating in shift changeovers, and communicating effectively with colleagues and leadership; escalates issues appropriately to minimize downtime and material loss, performs intermediate troubleshooting and equipment set-ups, and operates with limited supervision in routine situations.
• Additionally, supports team development by coaching and training operators on processes and product functionality, conducts thorough reviews of completed lot records including ERP material reconciliation, serves as a back-up lead when needed, and contributes to continuous improvement through workflow enhancements, improvement initiatives, and participation in R&D and experimental projects.

Requirements

• 5+ years’ manufacturing experience in a fast-paced GMP manufacturing environment.
• High school diploma or GED.

Qualifications

• Yellow Belt and/or lean certificate or equivalent.
• Certified Trainer or equivalent training experience.
• Demonstrated ability to learn multiple processes and provide mentoring to other operators.
• Proficient at intermediate level troubleshooting and set up activities on multiple processes.