Manufacturing Process Engineer | Continuous Improvement

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

Job summary

Amgen in the United States seeks a Manufacturing Specialist to support execution of manufacturing and quality systems, including continuous improvement and technology transfer. You will apply scientific expertise to optimize processes, train staff, and lead cross-functional initiatives.

The role emphasizes process ownership, risk assessments, and adherence to GMP while contributing to regulatory readiness and continuous improvement programs.

Qualifications

• Doctorate degree required.
• Master’s degree with 2+ years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Bachelor’s degree with 4+ years in related fields in pharma/biotech.
• Associates degree with 8+ years in relevant roles in pharma/biotech.
• High school diploma with 10+ years in engineering/manufacturing/quality in pharma/biotech.

Responsibilities

• Apply process expertise; initiate, revise, and approve manufacturing procedures reflecting current operations.
• Lead continuous improvement and support technology transfer / new product introductions.
• Assist in process monitoring, data review, and quarterly reports for deviations.
• Support NPIs, documentation, training, and equipment modification projects.
• Participate in investigations, CAPA closure, and trend evaluations.
• Assist with process validation protocols and data analysis.
• May participate in regulatory inspections and change control activities.

Skills

Bio-processing

Lean / Operational Excellence

GMP knowledge

Cross-functional teams

Data analysis

Education

Doctorate degree

Master’s degree + 2 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Bachelor’s degree + 4 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Associates degree + 8 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

High school diploma / GED + 10 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Job description

Amgen in the United States seeks a Manufacturing Specialist to support execution of manufacturing and quality systems, including continuous improvement and technology transfer. You will apply scientific expertise to optimize processes, train staff, and lead cross-functional initiatives.

The role emphasizes process ownership, risk assessments, and adherence to GMP while contributing to regulatory readiness and continuous improvement programs.