Technical Operator

Position Summary

The Senior Technical Operator is an advanced-level role responsible for operating, troubleshooting, and optimizing high-complexity manufacturing and packaging equipment in a cGMP environment. This position plays a critical role in equipment reliability, production efficiency, and the mentoring of junior operators and technicians.

The Senior Technical Operator serves as a technical expert for production equipment and processes, provides hands-on training, and collaborates with engineering and quality teams to drive process improvements and ensure regulatory compliance.

Key Responsibilities

• Perform advanced troubleshooting and root cause analysis on high-speed manufacturing, packaging, and supporting equipment.
• Conduct complex preventative and predictive maintenance tasks, ensuring compliance with manufacturer and internal standards.
• Lead equipment changeovers and set-ups, optimizing downtime and ensuring accuracy in product configurations.
• Collaborate with Engineering to recommend and implement process improvements for efficiency, safety, and quality enhancement.
• Maintain detailed maintenance and repair logs, ensuring compliance with cGMP documentation standards.
• Serve as subject matter expert (SME) for assigned equipment lines, assisting with capital project planning and validation activities.
• Mentor and train Technical Operators and other junior staff on troubleshooting, maintenance procedures, and cGMP best practices.
• Participate in continuous improvement initiatives (Lean, Six Sigma, Kaizen) to reduce waste and improve throughput.
• Assist Quality and Safety teams with investigations, CAPAs, and risk assessments.

Education & Experience

Required:

• High school diploma or equivalent.
• Minimum 4 years of experience in a manufacturing, operations, or production environment, with at least 3 years in a cGMP-regulated facility preferred.
• Demonstrated experience in mechanical, electrical, and pneumatic troubleshooting.

Preferred:

• Associate’s or bachelor’s degree in engineering technology, Industrial Maintenance, or related field.
• Advanced training or certifications in maintenance technology, PLC programming, or Lean Six Sigma.
• Experience in pharmaceutical or medical device manufacturing.

Knowledge, Skills, Abilities

• Strong mechanical and electrical aptitude, with proficiency in diagnosing and repairing complex automated systems.
• Skilled in using precision measuring devices and interpreting technical manuals, schematics, and diagrams.
• Knowledge of PLC-based control systems and automated production equipment.
• Proficiency in technical writing, including the ability to create clear, concise, and accurate documentation.
• Ability to lead projects, mentor staff, and work cross-functionally with Engineering, Quality, and Operations teams.
• Strong problem-solving, decision-making, and documentation skills.

Physical Requirements / Work Environment

• Ability to lift up to 50 lbs and perform repetitive movements.
• Ability to stand, walk, and work in production environments for extended periods.
• Work may involve exposure to temperature-controlled areas, noise, and production chemicals.