Line Mechanic

System One, Inc.; Stillwater Township (NJ); Presencial; USD 37 000 - 41 000; Tempo integral

Resumo da oferta

System One in Wharton, NJ is seeking a Line Mechanic to support manufacturing and facility operations. This on-site, direct-hire role offers hourly pay of $27.00–$30.00 and shifts across 1st, 2nd, and 3rd.

You will perform maintenance, repair, and troubleshooting of manufacturing, packaging, and utility equipment; conduct preventive maintenance and calibration; and help ensure FDA, ISO, and cGMP compliance while supporting audit readiness and continuous improvement.

Qualificações

• Associate’s or Bachelor’s degree in Mechanical Engineering, Industrial Maintenance, Electrical Engineering, Industrial Technology, or a related technical field.
• 3–5+ years of maintenance experience in FDA-regulated manufacturing environments.
• Strong knowledge of 21 CFR Parts 210 and 211 and current Good Manufacturing Practices.

Responsabilidades

• Perform maintenance, repair, and troubleshooting of manufacturing, packaging, utility, and facility equipment.
• Support maintenance of HVAC systems, purified water and DI water systems, compressed air, boilers, pumps, and related packaging machinery.
• Conduct preventive maintenance and calibration activities.
• Respond to equipment breakdowns and downtime to minimize impact on production.
• Maintain equipment uptime and support production schedules.
• Document maintenance activities, repairs, calibrations, and preventive maintenance records.
• Ensure FDA, ISO, cGMP, SOPs, and quality system compliance.
• Support inspection readiness for audits.
• Participate in change controls, CAPA, and deviation investigations.
• Operate and maintain facility utility systems and sanitation initiatives.
• Assist with equipment qualification/validation (IQ/OQ/PQ).

Conhecimentos

Troubleshooting

Preventive maintenance

Equipment calibration

FDA compliance

Safety procedures

Formação académica

Associate’s or Bachelor's degree in Mechanical Engineering/Industrial Maintenance/Electrical Engineering or related field

Ferramentas

CMMS

Descrição da oferta de emprego

Job Title: Line Mechanic

Location: Wharton, NJ

Type: Direct-Hire

Compensation: $27.00–$30.00/hour

Work Model: Onsite

Hours:

• 1st Shift: 7:00 AM–3:00 PM
• 2nd Shift: 3:00 PM–11:00 PM
• 3rd Shift: 11:00 PM–7:00 AM

Summary

The role supports manufacturing and facility operations through equipment maintenance, troubleshooting, preventive maintenance, calibration, utility support, and regulatory documentation. Key focus areas include equipment uptime, downtime reduction, preventive maintenance compliance, repair response times, and maintaining facility inspection readiness for FDA, ISO, customer, and internal audits.

Responsibilities

• Perform maintenance, repair, and troubleshooting of manufacturing, packaging, utility, and facility equipment.
• Support maintenance of HVAC systems, purified water and DI water systems, compressed air systems, boilers, pumps, mixing equipment, filling lines, labeling equipment, packaging machinery, and laboratory support equipment.
• Conduct preventive maintenance and calibration activities.
• Respond to equipment breakdowns and operational issues to minimize downtime.
• Maintain equipment uptime and support production schedules.
• Document maintenance activities, repairs, calibrations, and preventive maintenance records.
• Ensure compliance with FDA regulations, cGMP requirements, SOPs, and company quality systems.
• Support inspection readiness for FDA, customer, ISO, and internal audits.
• Participate in change controls, CAPA activities, deviation investigations, and equipment qualification programs.
• Operate and maintain facility utility systems, including HVAC, water systems, compressed air, electrical, and plumbing systems.
• Support contamination control and facility sanitation initiatives.
• Assist with equipment qualification and validation activities, including IQ, OQ, and PQ.
• Follow safety procedures, including Lockout/Tagout, PPE requirements, and chemical handling protocols.
• Maintain spare parts inventories and maintenance KPI reporting.
• Track downtime, equipment performance, and preventive maintenance completion rates.

Qualifications

• Associate’s or Bachelor’s degree in Mechanical Engineering, Industrial Maintenance, Electrical Engineering, Industrial Technology, or a related technical field. Equivalent experience may be considered.
• Minimum 3–5+ years of maintenance experience in cosmetic manufacturing, OTC drug manufacturing, pharmaceutical manufacturing, or other FDA-regulated industries.
• Strong knowledge of 21 CFR Parts 210 and 211.
• Strong knowledge of current Good Manufacturing Practices.
• Knowledge of utility systems, preventive maintenance systems, equipment troubleshooting, and facility management.
• Experience with computerized maintenance management systems.
• Knowledge of mechanical, electrical, pneumatic, and utility systems.
• Excellent troubleshooting, organizational, and communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Ability to work in manufacturing environments requiring PPE.
• Ability to stand, walk, bend, climb, and occasionally lift up to 50 pounds.
• Ability to work flexible schedules and respond to emergency maintenance situations.

Preferred Qualifications

• Experience supporting FDA inspections.
• Experience with ISO 22716 Cosmetic GMP systems.
• Experience with utility validation.
• Experience with water system maintenance.
• Experience with HVAC environmental controls.
• Experience supporting cleanroom systems.
• Experience with calibration programs.
• Familiarity with CAPA systems.
• Familiarity with change control systems.
• Familiarity with root cause investigations.
• Familiarity with energy management systems.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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