Senior Process Engineer - 3rd Party Tech Services

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Sr. Process Engineer, 3rd Party & Technical Services in Columbus, OH to lead process development, transfer, scale-up, and validation for both in-house and 3rd‑party products.

You will coordinate regulatory submissions, maintain quality standards, and mentor junior engineers across multiple dosage forms. You will drive collaboration with R&D, Quality, and Regulatory teams to ensure robust control strategies and timely product launches, supporting life‑cycle

Qualifications

• Bachelor’s degree with 6+ years of pharmaceutical experience; or Master’s with 4+ years; or Ph.D. with 2+ years.
• Experience in technology transfer, process development/validation, formulation, manufacturing, or quality in pharma.
• Strong knowledge of FDA, cGMP, and regulatory requirements (DEA, OSHA).
• Expertise in formulation development, process scale-up, validation/PPQ, and equipment.

Responsibilities

• Consult as Process and Formulation Champion on cGMP/FDA/Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/scale-up/validation for 3rd Party/CMO and in-house products.
• Lead as Hikma’s Technical Services representative for in-house process flow and equipment requirements; coordinate site visits and technical considerations.
• Drive gap and risk assessments including statistical data analysis for process scale-up and design/ initiatives like PAT/DOE.
• Lead strategy development for filing and validation, batch size planning, sampling, and records for registration scale-up, transfer and validation.

Skills

Process engineering

cGMP/FDA

DOE

CAPA

Technology transfer

Regulatory requirements

Data analysis

Formulation development

Scale-up/validation

Multiple dosage forms

Education

Bachelor’s degree in related field

Master’s degree in related field

Ph.D. in related field

Job description

Hikma Pharmaceuticals USA Inc. seeks a Sr. Process Engineer, 3rd Party & Technical Services in Columbus, OH to lead process development, transfer, scale-up, and validation for both in-house and 3rd‑party products.

You will coordinate regulatory submissions, maintain quality standards, and mentor junior engineers across multiple dosage forms. You will drive collaboration with R&D, Quality, and Regulatory teams to ensure robust control strategies and timely product launches, supporting life‑cycle