Senior Process Engineer, 3rd-Party & Tech Services

RXinsider LTD.; Columbus, Northern (OH, KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with Hikma match

Paid time off 20 days

Personal days 3

11 company holidays

Health, dental, vision

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Process Engineer, 3rd Party & Technical Services in Columbus, OH.

You will lead process development, validation, and transfer for both in-house and 3rd-party products, ensuring compliance with FDA and cGMP standards. This role requires collaboration across Quality, Regulatory Affairs, R&D, and Manufacturing, and involves mentoring engineers. Responsibilities include coordinating regulatory submissions, scaling-up processes, and driving process

Qualifications

• Bachelor’s degree in engineering, chemistry, pharmacy, or related field with 6+ years pharma experience.
• Master’s degree with 4+ years in a related field; or 7+ years experience with PhD.
• Experience in technology transfer, process development/validation, formulation, manufacturing, or quality within pharmaceuticals.
• Strong knowledge of FDA, cGMP, and regulatory requirements.
• Experience with multiple dosage forms (tablets, capsules, inhalation, semi-solids).

Responsibilities

• Lead process development, validation, and transfer for in-house and 3rd-party products.
• Coordinate regulatory submissions (ANDA, NDA, PAS) and cross-functional activities.
• Mentor junior engineers and promote best practices.
• Drive process improvement, CAPA, and risk assessments.
• Collaborate with Product Development, Production, QA, and DRA.
• Lead site visits and evaluation of 3rd party/CMO operations.

Skills

FDA knowledge

Process scale-up

DOE/experimental design

CAPA implementation

Cross-functional leadership

Problem solving

Documentation

Travel ability

Education

Bachelor’s degree in Engineering/Chemistry/Pharmacy

Master’s degree in related field

Ph.D. in related field

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Process Engineer, 3rd Party & Technical Services in Columbus, OH.

You will lead process development, validation, and transfer for both in-house and 3rd-party products, ensuring compliance with FDA and cGMP standards. This role requires collaboration across Quality, Regulatory Affairs, R&D, and Manufacturing, and involves mentoring engineers. Responsibilities include coordinating regulatory submissions, scaling-up processes, and driving process