Manufacturing Operator II

The Manufacturing Operator II is responsible for supporting manufacturing operations by operating production equipment, completing production documentation, ensuring product quality, and maintaining compliance with cGMP and Quality System requirements. This role works closely with production leads and supervisors to meet production goals while supporting continuous improvement initiatives in a fast-paced manufacturing environment.

Responsibilities

• Operate, set up, troubleshoot, and adjust production equipment under the direction of Production Leads or Supervisors.
• Manufacture and/or test products in accordance with cGMP requirements and Quality System procedures.
• Review, complete, and maintain SOPs, work instructions, batch records, and production documentation accurately.
• Read and interpret work orders, verify materials, and prepare production lines for manufacturing.
• Inspect raw materials and finished products throughout the manufacturing process.
• Assist Production Leads with job assignments and workflow coordination.
• Label, package, seal, and prepare finished products for shipment.
• Perform inventory and material transactions using QAD and other electronic management systems.
• Conduct line clearance activities, including material reconciliation and disposal.
• Clean and sanitize production equipment, workstations, and printers.
• Collaborate with production teams to resolve scheduling, equipment, and process issues.
• Support engineering activities related to process improvements and equipment validation.
• Participate in Lean Manufacturing, 5S, and Practical Process Improvement (PPI) initiatives.
• Follow all safety procedures and wear required Personal Protective Equipment (PPE).
• Perform additional production-related duties as assigned.

Required Skills

• High school diploma or equivalent required.
• Minimum of 1 year of manufacturing, production, operations, laboratory, or related experience.
• Knowledge of Microsoft Word and Excel.
• Ability to use electronic systems such as QAD and Oracle.
• Strong understanding of Good Documentation Practices (GDP).
• Excellent verbal and written English communication skills.
• Ability to read and interpret SOPs, work instructions, safety guidelines, and production documents.
• Basic mathematical skills.
• Strong organizational, multitasking, and problem-solving abilities.
• Ability to work effectively in a collaborative team environment.
• Experience working in a cGMP manufacturing environment.
• Knowledge of Good Warehouse Practices (GWP).
• Direct machine operation experience.
• Experience supporting process improvements and Lean manufacturing initiatives.
• Ability to lift up to 50 lbs without assistance.
• Ability to stand for extended periods throughout the shift.
• May work in cold environments (as low as -20 C) and around loud manufacturing equipment.
• Required to wear PPE including steel-toe shoes, gloves, lab coats, safety glasses, and hearing protection.
• Position involves handling controlled substances (Schedules I V) in compliance with DEA, FDA, and company regulations.
• Successful completion of a background check, including controlled substance screening, is required.

TekWissen Group is an equal opportunity employer supporting workforce diversity.