Qualifications

• Strong working knowledge of GMP, CFR regulations, and quality systems in a pharmaceutical or life sciences environment.
• Proven experience with documentation systems such as SOPs, CCMS, NCs, and work orders.
• Technical expertise in utility, building, and production system maintenance.
• Ability to read and interpret technical drawings and schematics.
• Strong attention to detail and organizational skills.
• Proficient in using CMMS or other electronic documentation platforms.

Responsibilities

• Perform advanced installation, troubleshooting, maintenance, repair, testing, and documentation of equipment used in manufacturing and utility plants.
• Develop, write, and complete a variety of technical and compliance documentation to meet GMP standards.
• Ensure all documentation is in compliance with GMP, CFR, and internal Amgen standards.
• Support operations of building and production systems with a focus on quality and efficiency.
• Increase safety and minimize production impact through proper execution of tasks and risk assessments.
• Provide training to staff on maintenance protocols and safety practices.
• Participate in audits and inspections, offering documentation support and technical guidance.

Benefits

• Work in a state-of-the-art manufacturing facility.
• Be part of a team that contributes to the production of life-changing therapies.
• Opportunity for hands-on problem-solving in a supportive environment.