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Specialist Technician, Production Equipment Repair & Maintenance (S3)

Position Summary

The Specialist Technician, Production Equipment Repair & Maintenance (S3) is responsible for executing preventive, predictive, corrective, and emergency maintenance activities on manufacturing equipment, utilities, automation systems, and production support equipment used in the manufacturing of medical devices.

This role ensures equipment reliability, uptime, product quality, safety, and regulatory compliance while supporting uninterrupted manufacturing operations within a highly regulated GMP environment. The Specialist Technician performs advanced troubleshooting, repair, calibration support, equipment qualification activities, and technical problem-solving while maintaining accurate and compliant maintenance documentation.

The position actively supports Quality Systems, regulatory compliance, continuous improvement initiatives, and operational excellence objectives. The technician serves as a technical resource for manufacturing operations and may provide guidance and mentorship to less experienced technicians.

Key Responsibilities

Equipment Maintenance & Reliability

• Execute preventive, predictive, corrective, and emergency maintenance activities on manufacturing equipment and support systems.
• Troubleshoot and repair electrical, mechanical, pneumatic, hydraulic, servo-controlled, electronic, automation, and electromechanical systems.
• Perform equipment inspections, adjustments, repairs, overhauls, alignments, and functional testing.
• Support maintenance strategies focused on equipment reliability and reduction of unplanned downtime.
• Support equipment installations, transfers, upgrades, qualifications, validations, and commissioning activities.
• Evaluate equipment conditions and proactively identify opportunities for reliability improvements.
• Assist Engineering teams with equipment modifications and continuous improvement projects.
• Support spare parts identification, inventory management, and critical parts recommendations.

• Assist in IQ, OQ, PQ, TMV, equipment qualifications, and validation protocols if required.
• Support implementation of validated maintenance practices and approved equipment changes.
• Verify equipment readiness prior to production release.
• Collaborate with Validation, Engineering, and Quality teams during equipment lifecycle activities.

Work Management & Documentation

• Execute maintenance activities in accordance with approved SOPs, work instructions, engineering specifications, and maintenance plans.
• Accurately document maintenance activities within the Computerized Maintenance Management System (CMMS) such as IBM Maximo or equivalent.
• Maintain complete, clear, accurate, contemporaneous, and audit-ready maintenance records following Good Documentation Practices (GDP).
• Ensure maintenance records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
• Complete work orders with detailed information regarding: Work performed Troubleshooting activities Replacement parts utilized Labor hours Equipment condition findings Follow-up actions.
• Maintain equipment history records to support reliability and asset management programs.
• Ensure timely completion and closure of assigned work orders.

Quality & Regulatory Compliance

• Comply with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable Quality System requirements.
• Maintain compliance with internal procedures, quality standards, and regulatory expectations.
• Support internal audits, external audits, regulatory inspections, and quality assessments.
• Participate in investigations related to deviations, nonconformances, complaints, equipment failures, and CAPA activities.
• Ensure maintenance activities do not adversely impact product quality, patient safety, data integrity, or regulatory compliance.
• Escalate quality, compliance, or equipment risks appropriately and in a timely manner.

Safety & EHS Responsibilities

• Adhere to all Environmental Health & Safety (EHS) requirements and safe work practices.
• Perform work in compliance with Lockout/Tagout (LOTOTO), electrical safety, machine guarding, confined space, and other applicable safety programs.
• Utilize required Personal Protective Equipment (PPE).
• Participate in safety observations, hazard identification, and risk reduction initiatives.
• Support a strong safety culture through proactive reporting and corrective action implementation.

Qualifications

Required Education

Technical Diploma, Specialist Technician Degree, Associate Degree, or equivalent technical certification in:

• Electromechanical Technology
• Industrial Maintenance
• Mechatronics
• Electronics Technology
• Electrical Technology
• Mechanical Technology
• Instrumentation & Controls
• Automation Technology
• Industrial Technology

Required Experience

• Minimum of 4 years of experience in industrial maintenance, manufacturing equipment maintenance, calibration, automation support, or equipment repair.
• Experience troubleshooting manufacturing equipment in a production environment.
• Experience performing preventive and corrective maintenance within a regulated manufacturing environment.
• Experience utilizing CMMS systems such as IBM Maximo, SAP PM, or equivalent.
• Experience complying with documented procedures and quality system requirements.

Required Knowledge & Skills

Technical Competencies

• Strong knowledge of industrial maintenance methodologies.
• Advanced troubleshooting skills for manufacturing equipment.
• Knowledge of: Electrical systems Mechanical systems Pneumatic systems Hydraulic systems PLC-controlled equipment Servo systems Sensors and instrumentation Automated manufacturing equipment
• Ability to read and interpret: Electrical schematics P&IDs Mechanical drawings Equipment manuals Technical specifications
• Knowledge of Good Manufacturing Practices (GMP).
• Knowledge of Good Documentation Practices (GDP).
• Understanding of medical device quality systems.
• Knowledge of data integrity principles and ALCOA+ requirements.
• Familiarity with: FDA regulations ISO 13485 requirements.
• Strong analytical and problem-solving skills.
• Effective verbal and written communication.
• Time management and organization skills.
• Ability to prioritize multiple tasks in a fast-paced manufacturing environment.
• Strong teamwork and collaboration skills.

Preferred Qualifications

• Experience in Medical Device Manufacturing.
• Experience in Pharmaceutical, Biotechnology, or FDA-regulated manufacturing environments.
• Experience supporting automated production lines.
• Knowledge in PLC troubleshooting (Allen Bradley, Siemens, or equivalent).

Other Requirements

• Ability to support overtime, weekends, holidays, and alternate shifts as required.
• Ability to work inside controlled manufacturing environments (cleanroom and non-cleanroom areas).
• Ability to comply with gowning requirements and contamination control procedures.
• Ability to lift equipment, tools, and materials according to company guidelines.
• Ability to wear required PPE and safely interact with manufacturing equipment.

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Preferred Skills: