Lead Operator/Technician

Title: Lead Operator/Technician
Location: Rochester City, NY

Lead Operators/Technicians - Work experience on automated manufacturing equipment, Preventive Maintenance, batch production. We are seeking a highly skilled and motivated Lead Operator/Technician with a strong background in operating and maintaining automated manufacturing equipment in a regulated environment. The ideal candidate will be responsible for supporting production operations, leading equipment setup and troubleshooting, executing preventive maintenance, and ensuring batch production runs meet Good Manufacturing Practices (GMP), ISO 13485, and FDA standards.

Key Responsibilities:
Operate and monitor automated and semi-automated manufacturing equipment used in the production of Class I, II, or III medical devices.
Lead day-to-day batch production activities, including equipment setup, changeovers, and documentation.
Perform and document preventive maintenance (PM) tasks per schedule on critical production equipment.
Troubleshoot mechanical, pneumatic, or electrical issues in coordination with the maintenance or engineering team.
Train and mentor junior operators and technicians in safe and compliant operation of equipment.
Ensure strict compliance with cGMP, FDA 21 CFR Part 820, and ISO 13485 standards.
Review batch records, maintain equipment logs, and ensure accuracy in production documentation.
Collaborate with cross-functional teams including quality assurance, process engineering, and validation.
Assist in equipment qualification and validation (IQ/OQ/PQ) activities as required.
Escalate production and quality issues promptly to the supervisor.
Participate in root cause investigations and support continuous improvement initiatives.
Maintain cleanliness and organization of the manufacturing area in accordance with 5S principles.
Support manufacturing during audits and inspections.
Suggest improvements in equipment performance, workflow efficiency, and operator safety.

Qualifications:
High School Diploma or equivalent required; Associate's degree or vocational training in a technical field preferred.
5+ years of hands-on experience in manufacturing operations in the medical device or pharmaceutical industry.
Strong understanding of automated manufacturing equipment such as thermoformers, ultrasonic welders, robotics, packaging lines, or cleanroom machinery.
Familiarity with preventive maintenance systems and CMMS (Computerized Maintenance Management System).
Working knowledge of batch production processes and relevant documentation.
Proficient in reading technical drawings, SOPs, and equipment manuals.
Excellent attention to detail, communication skills, and ability to lead small teams.
Comfortable working in a cleanroom and wearing appropriate PPE.
Experience with ERP systems (e.g., SAP, Oracle) and MES platforms is a plus.