Senior Process Engineer – Tech Services & 3P Transfers

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

PTO 20 days + holidays

Tuition reimbursement

Health, dental, vision benefits

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, Ohio, seeks a Sr. Process Engineer, 3rd Party & Technical Services to lead process development, validation, and transfers for in-house and CMO products.

You will oversee complex regulatory filings, ensure quality compliance, and mentor junior engineers across multiple dosage forms. The role focuses on collaboration with R&D, Product Development, and Production to optimize formulations, scale-up processes, and ensure timely product launches while

Qualifications

• Bachelor’s degree with 6+ years pharma experience, or higher degrees with more experience.
• Strong knowledge of FDA, cGMP, and regulatory requirements.
• Experience with multiple dosage forms (tablets, capsules, inhalation, semi-solids).
• Ability to lead cross-functional teams and influence stakeholders.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead process development, registration, and FDA filing tasks with 3rd party and Hikma.
• Coordinate with R&D, Product Development, and Production on scale-up and transfer.
• Mentor and develop other Technical Services staff.
• Drive CAPA, root cause analysis, and quality investigations.
• Prepare documentation for filings and regulatory submissions.
• Travel to 3rd party sites for transfer and validation activities.

Skills

Process development

Regulatory knowledge

DOE

Data analysis

Cross-functional leadership

Documentation

Problem solving

Communication

Travel flexibility

Education

Bachelor’s degree (Engineering/ Chemistry/ Pharmacy)

Master’s degree

Ph.D.

Tools

Process validation

QA systems

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, Ohio, seeks a Sr. Process Engineer, 3rd Party & Technical Services to lead process development, validation, and transfers for in-house and CMO products.

You will oversee complex regulatory filings, ensure quality compliance, and mentor junior engineers across multiple dosage forms. The role focuses on collaboration with R&D, Product Development, and Production to optimize formulations, scale-up processes, and ensure timely product launches while