Facilities Lead: GMP Maintenance & Reliability

Amgen SA; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen Thousand Oaks is seeking a Sr. Associate Facilities to provide maintenance leadership and technical expertise across drug substance facilities, ensuring systems operate within GMP guidelines and Amgen procedures.

The role leads maintenance planning, coordinates with QA and manufacturing, and drives reliability in utility spaces while adhering to CFRs and SOPs. On-call rotations are required; candidates should bring strong problem-solving, communication, and team coordination skills in a

Qualifications

• Bachelor’s or higher in a relevant field with maintenance experience.
• Experience in FDA/GMP environments preferred.
• Strong planning and problem-solving abilities.

Responsibilities

• Advise, plan, and delegate tasks to personnel in daily operations, corrective actions, and preventive maintenance for multiple drug substance facilities.
• Perform planned maintenance and emergency repairs of production-related facilities components.
• Prioritize daily activities with QA and management to avoid production impact.
• Maintain an environment with flexible maintenance practices and efficient operations.
• Develop and maintain inventory control for spare parts.
• Create and revise SOPs and job plans for maintenance operations.
• Interact with support departments and vendors to meet facility equipment needs.
• Act as owner/SME for water-based utilities and support internal/regulatory audits.
• Evaluate maintenance procedures and ensure change control and QA notification.
• Work in accordance with CFRs, cGMPs, SOPs and Amgen policies.
• Participate in On-Call rotations and may work outside hours.

Skills

Maintenance leadership

GMP compliance

Problem solving

Communication skills

Analytical thinking

Team coordination

Education

Master’s degree in Engineering or related field

Bachelor’s degree with 6 months maintenance experience

Associate’s degree with 2 years maintenance experience

High school diploma or GED with 4 years maintenance experience

Tools

Power and hand tools

Facility automation basics

Job description

Amgen Thousand Oaks is seeking a Sr. Associate Facilities to provide maintenance leadership and technical expertise across drug substance facilities, ensuring systems operate within GMP guidelines and Amgen procedures.

The role leads maintenance planning, coordinates with QA and manufacturing, and drives reliability in utility spaces while adhering to CFRs and SOPs. On-call rotations are required; candidates should bring strong problem-solving, communication, and team coordination skills in a