Senior Technical Engineer: GMP Maintenance & Systems

Amgen SA; New Albany (OH); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a maintenance engineering professional to provide technical mechanical and electrical support across system optimization strategies, upgrades, repairs, and modifications. You will help ensure compliance with industry and FDA standards in the Inspection and Packaging areas.

The role involves coordinating maintenance activities, supporting regulatory inspections, leading a team of technicians on mechanical and electrical breakdowns, and contributing to continuous improvement

Qualifications

• Master’s degree or equivalent in Mechanical/Electrical/Engineering.
• Alternate qualifications listed: bachelor’s +2 years or associate+6 years or high school +8 years in technical engineering.
• Experience with regulated manufacturing environments (GMP/pharma) preferred.
• Familiarity with maintenance, calibration, and process optimization.

Responsibilities

• Take part in the coordination of tech support on engineering, regulatory, compliance, quality, technical cleaning, validation, and mechanical/electrical equipment issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Assist in planning, scheduling, and coordinating maintenance activities.
• Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
• Investigate complex issues or problems.
• Assist with maintaining an up‑to‑date working spare parts inventory system for the equipment/systems.
• Create maintenance procedures and assist in changes to optimize the maintenance program, troubleshoot and repair equipment/system failures.
• Develop technical guides and trainings for repetitive tasks.
• Provide training to others for continuous team development.
• Be the point of contact for leading a team of technicians on mechanical and electrical breakdowns.
• Identify improvement opportunities and lead small projects.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.

Skills

Communication skills

Mechanical troubleshooting

Problem solving

MS Office proficiency

Education

Master’s degree

Bachelor’s degree and 2 years of Technical Engineering experience

Associate’s degree and 6 years of Technical Engineering experience

High school diploma / GED and 8 years of Technical Engineering experience

Tools

Maximo 7

Cognex Vision System

Systech Serialization

PLC knowledge

Job description

Amgen is seeking a maintenance engineering professional to provide technical mechanical and electrical support across system optimization strategies, upgrades, repairs, and modifications. You will help ensure compliance with industry and FDA standards in the Inspection and Packaging areas.

The role involves coordinating maintenance activities, supporting regulatory inspections, leading a team of technicians on mechanical and electrical breakdowns, and contributing to continuous improvement