Production Operator

Job Description

Job Description

Coppell, TX

Contract Duration : 2-36 months

Rate : Negotiable

Responsibilities :

• Excellent employment opportunity for a Production Operator in the Coppell, TX area.
• As a member of the Manufacturing team contribute through performing varying tasks related to the ongoing manufacture of high quality active pharmaceutical ingredients including the drafting of manufacturing documents.
• Responsible for performing a variety of large-scale API manufacturing tasks (weighing and dispensing of chemicals, chemical reactions at high temperature and pressures, mixing, filtering, drying, and packaging) and activities to achieve prescribed level of purity, quality and consistency in product and work output.
• Ethical conduct and compliance
• Performs process manufacturing tasks including operation of large-scale equipment, weighing, measuring, monitoring of raw materials to assure batches contain proper ingredients, quantities and process outputs
• Performs in-process testing as specified within manufacturing documentation.
• Identifies and informs supervisor of equipment malfunctions or process outputs that do not meet expected outcomes.
• May perform trouble shooting of equipment or process problems and recommend solutions
• Maintains manufacturing areas to identified standards of cleanliness and neatness; may involve sweeping, mopping floors, wiping down equipment, and appropriately disposing of trash.
• Operate electric and manual hand or fork trucks as required to properly move and store chemicals and product.
• May be required to write or revise process documents such as operational SOP's, batch records, etc.
• Participates in LEAN principles within Manufacturing.
• Leads daily meetings as required.
• Escalates issues to appropriate departments (Sr Operator, Maintenance, Metrology, QA, Process Facilitator).
• Completes Overall Equipment Efficiency (OEE) reporting each shift.
• Reviews executed Batch Records.
• Completes Training deficiencies in a timely manner.
• Completes Weekly / Monthly Manufacturing activities / Cleans
• Completes SAP for assigned work, and follows up on SAP issues (shift to shift and / or SAP Global Team)
• Completes Autonomous Maintenance and 5s audits as scheduled.
• Performs GENBA walk of area(s) / Equipment of responsibility.
• Performs Logbook Audits on a weekly basis

Experience :

• High School Diploma or GED
• Individual must possess mechanical aptitude and ability to work with hands and tools to operate and perform minor maintenance on equipment.
• Must be able to operate basic electronic equipment and possess basic computer skills.
• Must be able to follow directions, both written and verbal, and perform assigned tasks independently.
• Must be able to read, write, and understand English
• Requires understanding of basic math to perform mathematical calculations.
• Must be able to wear a half face respirator where needed.
• Ability to exert an amount of force continuously and / or up to 5 pounds of force frequently and / or up to 25 pounds of force occasionally and / or up to 50 pounds of force occasionally by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Desirable :
• College course work in Science
• Compounding experience
• 2+ Years of Experience in a cGMP Pharmaceutical environment or regulated industry
• Reliable attendance and ability to work flexible hours, including weekends and overtime as needed, are required.
• Shift : 1 Day Shift (7am-7pm); 1 Night Shift (7pm-7am)

Work Schedule : Week 1- Mon / Tues ON, Wed / Thu OFF, Fri / Sat / Sun ON

Work Schedule : Week 2 - Mon / Tue OFF, Wed / Thu ON, Fri / Sat / Sun OFF