Production Operator

Key Responsibilities

The Production Operator will be responsible for supporting manufacturing operations while ensuring compliance with quality, safety, and regulatory requirements. Responsibilities include:

• Configure, operate, and monitor automated, semi-automated, and manual manufacturing equipment according to established process specifications.
• Interpret work instructions, manufacturing specifications, and operating procedures to correctly set up and adjust equipment.
• Perform machine setup, changeovers, and basic troubleshooting activities to maintain production efficiency and minimize downtime.
• Conduct preventive maintenance activities and promptly communicate equipment issues requiring further repair or maintenance.
• Assemble products and perform quality inspections in accordance with GMP, QS Regulations, and applicable manufacturing standards.
• Verify products during the manufacturing process, identify non-conforming materials, and support corrective actions when necessary.
• Maintain accurate and complete manufacturing documentation, production records, and batch-related documentation to ensure compliance and traceability.
• Perform batch reconciliation and transfer materials to appropriate production and inventory locations.
• Maintain cleanroom and production areas by performing routine cleaning and sanitization activities according to established procedures.
• Support environmental monitoring activities, including temperature, humidity, pressure differential monitoring, particle readings, and metal detection testing when applicable.
• Handle chemicals, cleaning agents, and manufacturing materials in accordance with environmental, health, and safety requirements.
• Participate in continuous improvement initiatives, process optimization projects, cross-training programs, and operational excellence activities.
• Ensure compliance with all company policies, GMP/QSR requirements, quality standards, environmental regulations, and occupational health and safety procedures.
• Utilize appropriate Personal Protective Equipment (PPE) and contribute to maintaining a safe and compliant work environment.

Qualifications

• High School Diploma required; college studies preferred.
• Two (2) or more years of manufacturing or related work experience preferred.
• Basic computer proficiency (Microsoft Windows, MES, HMI, and related systems).
• Basic mathematical skills, including addition, subtraction, multiplication, division, and percentages.
• Strong manual dexterity, hand-eye coordination, and attention to detail.
• Ability to work effectively in a fast-paced, highly regulated manufacturing environment.
• Strong teamwork, communication, and problem-solving skills.
• Flexibility to work different shifts, overtime, weekends, and holidays as required by business needs.