Maintenance Technician

Barrington James; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading recruitment agency is seeking a Lead Process Equipment Maintenance Technician in Irvine, California. This role is crucial for maintaining and troubleshooting Aseptic Fill-Finish manufacturing equipment. Candidates should have at least 8 years of experience and strong technical skills in a GMP environment. Responsibilities include leading maintenance activities, documenting work accurately, and participating in on-call coverage. This position offers an opportunity to be pivotal to manufacturing operations, ensuring equipment reliability and efficiency.

Qualifications

• Minimum of 8 years of experience in a similar technical or maintenance role.
• Experience working in GMP environments.
• Hands-on skills in electrical and pneumatic systems.
• Advanced hands-on technical skills in mechanical, electrical, and pneumatic systems within GMP environments.
• Ability to meet cleanroom gowning requirements.
• Minimum of 8 years of experience in a similar technical or maintenance role.

Responsibilities

• Perform maintenance and troubleshooting on process equipment.
• Coordinate and execute work orders and preventive maintenance.
• Lead shutdown activities as an SME.
• Complete necessary GMP documentation.
• Participate in on-call coverage.
• Participate in APS interventions as required.
• Complete and support all necessary GMP documentation, including investigations, CAPAs, and change controls.
• Provide support for site projects involving equipment or facility upgrades.
• Participate in on-call coverage for production operations.

Skills

Strong written communication skills

Proficiency in computer-based systems

Ability to diagnose and repair complex equipment

Advanced technical skills in mechanical systems

Ability to meet cleanroom gowning requirements

Cleanroom gowning

Problem diagnosis

Communication skills

On-call support

Documentation & CAPA

Education

High school diploma

Advanced technical training

Job description

Reporting to the Manager of Facilities, the Lead Process Equipment Maintenance Technician is responsible for supporting Aseptic Fill-Finish manufacturing operations by maintaining and troubleshooting production equipment. This role serves as the primary responder for equipment-related issues on the production floor and participates in a paid rotational on‑call schedule.

PRIMARY RESPONSIBILITIES

• Perform maintenance and troubleshooting on process equipment, including autoclaves, fill lines, washers, ovens, lyophilizers, and HVAC systems.
• Coordinate and execute work orders and preventive maintenance activities.
• Serve as a Subject Matter Expert (SME) for equipment maintenance tasks.
• Lead and support equipment‑related shutdown activities as an SME.
• Conduct pre‑operational checks on process equipment.
• Participate in APS interventions as required.
• Complete and support all necessary GMP documentation, including investigations, CAPAs, and change controls.
• Provide support for site projects involving equipment or facility upgrades.
• Participate in on‑call coverage for production operations.

QUALIFICATIONS & EXPERIENCE

• Strong written communication skills with the ability to accurately document work.
• Proficiency in computer‑based systems and adherence to cGDP.
• Ability to diagnose and repair complex equipment, systems, and controls.
• Advanced hands‑on technical skills in mechanical, electrical, and pneumatic systems within GMP environments.
• Ability to meet cleanroom gowning requirements.
• High school diploma required; advanced technical training preferred.
• Minimum of 8 years of experience in a similar technical or maintenance role.