Senior Manufacturing Engineer — Process & Quality Support

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen is seeking a Sr. Associate in Manufacturing - Engineering Support to join our team in advancing patient care. You will support manufacturing systems, drive process improvements, and help ensure compliance with regulatory requirements across production operations.

You will collaborate on technology transfer, NPIs, process validation, and CAPA activities, shaping scalable processes and robust procedures in a fast-paced biotech environment.

Qualifications

• Experience in pharmaceutical, medical device or biotechnology manufacturing environments.
• Ability to develop and implement process improvements and manage cross-functional projects.
• Knowledge of GMP, regulatory expectations, and change control processes.

Responsibilities

• Apply process expertise to manage manufacturing procedures and reflect current operations.
• Assess performance via floor observations, data review, and troubleshooting.
• Lead continuous improvement and cost/cycle-time reduction initiatives.
• Support technology transfer, NPIs, and equipment modifications.
• Conduct risk evaluations and generate summary reports for changes.
• Support process validation, CAPA investigations, and regulatory inspections.
• Assist with CCRB change assessments and control plans.

Skills

Process engineering

Manufacturing

Quality systems

Lean/Six Sigma

GMP knowledge

Regulatory knowledge

Project management

Data analysis

Root cause analysis

Technical writing

Education

High school/GED + 4 years in Engineering, Manufacturing, Packaging or Quality experience

Associates + 2 years in Engineering, Manufacturing, Packaging or Quality experience

Bachelors + 6 months in Engineering, Manufacturing, Packaging or Quality experience

Master's

Job description

Amgen is seeking a Sr. Associate in Manufacturing - Engineering Support to join our team in advancing patient care. You will support manufacturing systems, drive process improvements, and help ensure compliance with regulatory requirements across production operations.

You will collaborate on technology transfer, NPIs, process validation, and CAPA activities, shaping scalable processes and robust procedures in a fast-paced biotech environment.