Senior Process Engineer, 3rd-Party Transfer & Manufacturing

RXinsider LTD.; Columbus (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Sr. Process Engineer, Third Party Management to lead transfers of external products from R&D to Commercial Operations.

You will champion cGMP compliance, drive scale-up, validation, and site transfers, and coordinate regulatory filings with cross-functional teams. The role requires strong collaboration with Product Development and Regulatory Affairs, with a focus on risk assessment, QbD, and continuous process improvement to support timely

Qualifications

• BS/MS/PhD in Engineering or related field with pharma tech transfer exposure.
• Experience in process transfer, scale-up, and validation.
• Knowledge of FDA regulatory expectations (FDA filings, cGMP).

Responsibilities

• Lead transfer of 3rd party/CMO products from R&D to Commercial Operations.
• Coordinate QC investigations, deviations, and CAPAs.
• Drive process scale-up/validation and site transfers.
• Collaborate with Regulatory Affairs and Product Development.
• Support risk assessments and QbD-based development activities.
• Lead cross-functional teams to ensure on-time product launches.

Skills

Process transfer

cGMP

FDA filings

Quality assurance

Project management

Process validation

DOE

QbD

Cross-functional leadership

CAPA

Education

BS in Engineering

MS in Engineering

PhD in Engineering

Tools

LIMS

SAP

Quality systems

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Sr. Process Engineer, Third Party Management to lead transfers of external products from R&D to Commercial Operations.

You will champion cGMP compliance, drive scale-up, validation, and site transfers, and coordinate regulatory filings with cross-functional teams. The role requires strong collaboration with Product Development and Regulatory Affairs, with a focus on risk assessment, QbD, and continuous process improvement to support timely