Pharmaceutical Product Operator - 3rd Shift

Job Summary

The Pharmaceutical Product Operator is responsible for executing cloth converting and/or packaging processes in a controlled ISO-classified cleanroom environment. This role ensures adherence to contamination control practices, SOP/GMP compliance, accurate batch documentation, and safe handling of cloth, film, and solution contact components. Operators serve on the front line of aseptic behavior, environmental discipline, and product integrity, supporting compliant and efficient manufacturing operations.

Job Description

MAJOR RESPONSIBILITIES

Cleanroom Conduct & Gowning 

• Follow all cleanroom gowning requirements and adhere to gowning and material entry protocols. 

• Follow good aseptic practices when performing all tasks within ISO-certified environments.  

Pre-Run Preparation 

• Complete all pre-run checks, including:  

• Line clearance procedures 

• Verifying production parameter sheets and counter readings 

• Checking machine cleanliness status 

• Accurate documentation 

Cloth Converting Operations 

• Load cloth rolls using approved cleanable dollies or carts, minimizing manual handling. 

• Set up and operate unwind stations, tension controls, alignment systems, folding boards, and cutting mechanisms according to validated line parameters. 

• Monitor dosing application (when applicable), including flow rate, nozzle alignment, and solution coverage. 

• Continuously inspect the web path for defects (tears, fraying, or contamination) and adjust as needed. 

• Perform required hourly inspections and document results. 

OR 

Packaging Line Operations 

• Load film rolls using approved cleanable carts or lifts, minimizing manual handling. 

• Set up and maintain packaging parameters within validated specifications. 

• Set up and verify date/lot coding equipment and inspection verification systems. 

• Perform required hourly inspections and document results. 

Documentation & Escalation 

• Real-time, accurate, and complete documentation on all forms and records. 

• Follows Good Documentation Practices 

• Immediately escalate deviations to the Supervisor or Quality. 

Cleaning & Responsibilities 

• Perform cleaning activities according to established procedures. 

• Assist with sanitization steps for all tools/equipment and execute proper changeover cleaning sequences. 

• Handle scrap per established procedure and ensure scrap receptacles never leave the cleanroom. 

Safety & Ergonomics 

• Follow all EHS procedures, including chemical handling requirements. 

• Use proper ergonomic techniques when lifting cloth rolls and moving materials. 

MINIMUM JOB REQUIREMENTS

Education

• High school diploma or GED required 

Work Experience

• Experience in aseptic manufacturing environment 

Knowledge / Skills / Abilities

• Effective communication and interpersonal skills, including the ability to guide and collaborate with others. 

• Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements. 

• Other duties as assigned. 

• Flexibility to work mandatory overtime based on business needs. 

• Ability to speak, read, and write English with proficiency   

PREFERRED JOB REQUIREMENTS

Work Experience

• Hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing. 

Knowledge / Skills / Abilities

• Strong working knowledge of GMP regulations, aseptic techniques, and biopharmaceutical manufacturing processes, with the ability to execute work in compliance with SOPs, batch records, and technical documentation. 

• Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment. 

• Demonstrated attention to detail with the ability to accurate