Sr. Process Engineer, Technical Services — Scale‑Up & Transfer

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

PTO 20 days

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH, is seeking a Sr. Process Engineer in Technical Services.

You will lead process development, registration, and transfer for in-house and 3rd-party products, ensuring compliance with FDA and cGMP requirements, and drive scale-up, validation, and lifecycle management across dosage forms. You will mentor junior engineers, coordinate regulatory submissions, and collaborate with product development, production, and QA to optimize processes and ensure

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmacy, or related field with 6+ years of pharma experience or 9+ years in a related field.
• Experience in technology transfer, process development/validation, formulation, manufacturing, or quality within pharmaceuticals.
• Strong knowledge of FDA, cGMP, and regulatory requirements (DEA, OSHA, etc.).
• Expertise in formulation development, process scale-up, validation/PPQ, and equipment.

Responsibilities

• Lead process development, registration, and FDA filing tasks with R&D and project teams.
• Coordinate regulatory submissions and cross-functional activities while mentoring junior engineers.
• Lead transfers and scale-up/validation batches for 3rd party/CMO and in-house products.
• Drive process improvement initiatives and CAPA during commercial manufacturing and CPV.
• Mentor Technical Services team and promote knowledge transfer.

Skills

Process engineering

cGMP

DOE

Regulatory compliance

Data analysis

Education

Bachelor's degree in Engineering or related field

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, OH, is seeking a Sr. Process Engineer in Technical Services.

You will lead process development, registration, and transfer for in-house and 3rd-party products, ensuring compliance with FDA and cGMP requirements, and drive scale-up, validation, and lifecycle management across dosage forms. You will mentor junior engineers, coordinate regulatory submissions, and collaborate with product development, production, and QA to optimize processes and ensure