Process Engineer

Job Summary:

The Process Engineer will support the design, optimization, and continuous improvement of manufacturing processes within a pharmaceutical production environment. This role ensures that processes meet quality, safety, and regulatory standards while maximizing efficiency and reliability. The ideal candidate will collaborate closely with cross-functional teams to troubleshoot issues, implement process improvements, and support technology transfer and scale-up activities.

Responsibilities:

• Develop, optimize, and validate manufacturing processes to ensure consistent product quality and compliance with cGMP standards.
• Lead process investigations and implement corrective and preventive actions (CAPAs).
• Support technology transfer, scale-up, and new product introduction activities.
• Analyze process data to identify trends and recommend process improvements.
• Collaborate with Quality, Validation, and Production teams to ensure smooth manufacturing operations.
• Author and review technical documentation, including SOPs, batch records, and process validation protocols.
• Ensure adherence to safety, environmental, and regulatory requirements.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, or related field.
• Minimum of 3 years of experience in a pharmaceutical manufacturing environment.
• Strong understanding of cGMP, process validation, and regulatory compliance.
• Proficiency in process modeling, data analysis, and continuous improvement methodologies (e.g., Lean, Six Sigma) preferred.