Sr. Process Engineer — 3rd Party & Tech Services

RXinsider LTD.; Columbus (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with Hikma match

20 days PTO

11 company paid holidays

Health, dental, vision

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, Ohio, is seeking a Sr. Process Engineer for 3rd Party & Technical Services to lead process development, validation, and transfer for in-house and CMO products, ensuring compliance with cGMP and regulatory standards.

You will drive risk assessments, scale-up, and lifecycle management across multiple dosage forms, mentor engineers, and coordinate with DRA and QA to accelerate filings and commercial manufacture.

Qualifications

• Bachelor's degree with 6+ years of relevant pharmaceutical experience or 9+ years in a related technical 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.).
• Ability to lead cross-functional teams and influence internal/external stakeholders.

Responsibilities

• Consult as Process and Formulation Champion on cGMP/FDA/Hikma quality requirements and execute process registration, scale-up, validation and commercial production for 3rd Party/CMO & in-house products.
• Lead as Hikma's Technical Services representative for in-house process flow and equipment requirements and spearhead site visits and evaluations.
• Drive gap and risk assessments including statistical data analysis for process scale-up and design/improvement initiatives.
• Lead strategy development for filing and validation, including lot sizes, sampling plans, and batch records for registration scale-up and transfer.
• Create or review documentation and master data for production of batches for registration/filing/scale-up and validation.
• Mentor and develop other members of Technical Services and promote knowledge transfer.

Skills

Cross-functional leadership

Data analysis

Regulatory alignment

Problem solving

Education

Bachelor's degree in Engineering, Chemistry, or Pharmacy

Master's degree in related field

PhD in related field

Tools

DOE (Design of Experiments)

Process scale-up equipment knowledge

FDA regulatory familiarity

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, Ohio, is seeking a Sr. Process Engineer for 3rd Party & Technical Services to lead process development, validation, and transfer for in-house and CMO products, ensuring compliance with cGMP and regulatory standards.

You will drive risk assessments, scale-up, and lifecycle management across multiple dosage forms, mentor engineers, and coordinate with DRA and QA to accelerate filings and commercial manufacture.