Process Engineer

We are seeking a dynamic and detail-oriented Process Engineer to join our Manufacturing Operations team focused on drug development and production. This role is critical to driving the scalability, efficiency, and quality of manufacturing processes within a fast-paced, regulated environment.

Key Responsibilities

Design, implement, and optimize manufacturing processes for clinical and commercial drug products.

Support tech transfer activities from R&D to manufacturing, ensuring robust and scalable process design.

Troubleshoot process issues and collaborate with cross-functional teams to identify root causes and implement corrective actions.

Generate and maintain documentation including batch records, protocols, reports, and SOPs in compliance with cGMP.

Lead or support process validation, equipment qualification, and continuous improvement initiatives.

Collaborate closely with Quality, Regulatory, R&D, and Engineering teams to ensure manufacturing readiness and regulatory compliance.

Analyze process data to monitor trends, identify deviations, and propose proactive solutions.

Qualifications

Bachelor’s or Master’s in Chemical Engineering, Pharmaceutical Sciences, Biotech, or related field.

2–5 years of experience in a pharmaceutical/biotech manufacturing environment (GMP experience preferred).

Familiarity with drug development lifecycle from preclinical to commercial scale.

Strong understanding of process scale-up, tech transfer, and validation principles.

Excellent problem-solving, communication, and cross-functional collaboration skills.

Nice to Have

Experience with aseptic processing, biologics, or continuous manufacturing.

Exposure to quality systems, change control, and CAPA management.