Operator - Coppell, TX - Operations

Role Summary

Operator - Coppell, TX - Operations. Responsible for performing a variety of large-scale API manufacturing tasks, including weighing and dispensing chemicals, chemical reactions, mixing, filtering, drying, and packaging, to achieve prescribed levels of purity, quality, and consistency in product output. Night shift position (rotating 2 weeks from 6:30pm to 7:00am).

Responsibilities

• Ethical conduct and compliance
• Operate large scale equipment, weigh and measure raw materials, and monitor batches to ensure accurate ingredients, quantities, and process outputs
• Perform in-process testing as specified in manufacturing documentation
• Identify equipment malfunctions or non-conforming outputs; troubleshoot and recommend solutions
• Maintain clean and neat manufacturing areas; dispose of trash appropriately
• Operate electric and manual hand or fork trucks as required
• Write or revise process documents such as SOPs and batch records as needed
• Participate in LEAN principles within Manufacturing
• Other duties as assigned
• Lead daily meetings as needed
• Complete Overall Equipment Efficiency (OEE) reporting each shift
• Review completed Batch Records
• Complete training deficiencies promptly
• Complete weekly/monthly manufacturing activities and cleaning
• Complete SAP entries for assigned work and follow up on SAP issues
• Complete Autonomous Maintenance and 5S audits as scheduled
• Perform GENBA walk of area/equipment of responsibility
• Perform weekly log book audits

Qualifications

• High school diploma/GED
• 0-2 years in a cGMP pharmaceutical or regulated setting
• Mechanical skill to operate and perform minor maintenance on equipment
• Ability to use basic electronic equipment and basic computer skills
• Ability to follow instructions and perform duties autonomously
• Ability to read, write, and understand English
• Understanding of basic math for calculations
• Ability to wear a half-face respirator where needed
• Physical ability to exert up to 50 pounds of force occasionally; ability to lift/move objects with hand truck
• Reliable attendance and ability to work flexible hours, including weekends and overtime

Skills

• Mechanical aptitude
• Attention to detail
• Problem-solving and troubleshooting
• LEAN manufacturing principles
• SAP and batch record workflows

Education

• Not specified beyond diploma/ GED; college coursework in science is preferred