Director of Engineering - GMP Operations

BioSpace; New Albany (OH); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Stock-based incentives

Flexible work models

Retirement plan

Medical/dental/vision insurance

Job summary

Amgen seeks a Director of Engineering to lead the engineering and maintenance teams supporting the assembly and packaging lines in a 24/7 operation. You will provide strategic direction, drive safety, and ensure GMP compliance across the site.

You will manage a dynamic team, coordinate with cross-functional partners, and deliver improvements in equipment reliability, capital projects, and process optimization within a highly regulated biopharma environment.

Qualifications

• Doctorate degree and 4 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Masters degree and 8 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
• Bachelor's degree and 10 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Responsibilities

• Lead engineering and maintenance teams supporting GMP operations in a 24/7 site.
• Ensure safety of personnel and adherence to GMP standards and procedures.
• Develop and manage department budgets, KPIs, and project roadmaps.
• Oversee audits, regulatory readiness, and partner interactions.
• Drive continuous improvements in equipment reliability and process performance.
• Present plans and progress to stakeholders and manage design approvals.

Skills

Leadership experience

GMP experience

Regulatory compliance

Strategic problem solving

Education

Doctorate degree with manufacturing/quality focus

Master's degree in relevant field

Bachelor's degree in relevant field

Job description

Amgen seeks a Director of Engineering to lead the engineering and maintenance teams supporting the assembly and packaging lines in a 24/7 operation. You will provide strategic direction, drive safety, and ensure GMP compliance across the site.

You will manage a dynamic team, coordinate with cross-functional partners, and deliver improvements in equipment reliability, capital projects, and process optimization within a highly regulated biopharma environment.