Process Engineer – Manufacturing Innovator (Flexible Work)

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision

Flexible work models

Job summary

Amgen is seeking a Specialist, Manufacturing to support manufacturing and quality systems. You will apply process, scientific, and compliance expertise to ensure procedures reflect current operations and drive continuous improvement.

The role involves technology transfer, process validation, and participation in regulatory inspections, with opportunities for training and professional growth within a collaborative, science-driven culture.

Qualifications

• Doctorate or equivalent in a relevant field with experience in pharma/biotech manufacturing.
• Advanced degree holders with 2+ years in engineering, manufacturing, packaging or quality are considered.
• High school diploma with 10 years in applicable experience acceptable under the alt-qualification path.

Responsibilities

• Initiate, revise, and approve manufacturing procedures to reflect current operations.
• Assess process performance via floor observations and data reviews; troubleshoot as needed.
• Plan and implement process-improvement solutions and train personnel on new methods.
• Support technology transfer, NPIs, and equipment modifications with proper documentation.
• Lead investigations for non-conformances and assist with CAPA closure.

Skills

Lean principles

GMP production operations

Process validation

Data analysis

Regulatory knowledge

Cross-functional collaboration

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

Job description

Amgen is seeking a Specialist, Manufacturing to support manufacturing and quality systems. You will apply process, scientific, and compliance expertise to ensure procedures reflect current operations and drive continuous improvement.

The role involves technology transfer, process validation, and participation in regulatory inspections, with opportunities for training and professional growth within a collaborative, science-driven culture.