Biopharma Maintenance Engineer: Reliability & GMP

AGC Biologics, Inc.; København; On-site; DKK 650,000 - 900,000; Full time

Job summary

AGC Biologics is seeking a Maintenance Engineer to strengthen performance, reliability, and efficiency of production and utility equipment in a GMP environment. You will help develop maintenance strategies and lead improvements to ensure compliant, cost-effective operations.

The role emphasizes structured improvements, collaboration with PMO, and support for qualification activities. English fluency is required; Danish is a plus. Based in Denmark, relocation is not offered.

Qualifications

• MSc, BSc, or BE in Mechanical, Electrical, Machine or Production Engineering (or similar).
• Several years in maintenance or reliability engineering or related tech functions.
• Solid understanding of regulatory requirements and documentation.
• Strong analytical ability to translate data into improvements.
• Excellent collaboration and communication skills.

Responsibilities

• Develop, implement, and maintain robust maintenance strategies (preventive, predictive, condition-based).
• Conduct FMECA and risk assessments to prioritize improvements and define plans.
• Assess and adjust spare parts strategies to support reliability.
• Coordinate Life Cycle Asset Management with the PMO department.
• Act as SME on reliability engineering methods on site.
• Support commissioning and qualification of new equipment.
• Perform root cause analyses on failures, deviations, and downtimes.

Skills

English fluent

Analytical skills

Communication

Reliability engineering

Education

MSc/BSc/BE in Mechanical, Electrical, Machine or Production Engineering

Job description

AGC Biologics is seeking a Maintenance Engineer to strengthen performance, reliability, and efficiency of production and utility equipment in a GMP environment. You will help develop maintenance strategies and lead improvements to ensure compliant, cost-effective operations.

The role emphasizes structured improvements, collaboration with PMO, and support for qualification activities. English fluency is required; Danish is a plus. Based in Denmark, relocation is not offered.