Associate Process Engineer

About the Role

The Associate Process Engineer supports operations by implementing improvements, validation, and automation in plant operations. This role involves assisting with standard operating procedures (SOPs), process development, and reviewing design documents for new equipment.

Key Responsibilities

• Support process/validation engineers for plant operations to suggest and implement improvements for new manufacturing processes through process and equipment validation.
• Complete process simulations and optimization studies.
• Implement modifications and process installations at the manufacturing level.
• Support day-to-day manufacturing operations by monitoring process performance and identifying improvement opportunities.
• Assist in process optimization to improve yield, efficiency, quality, and equipment reliability.
• Analyze manufacturing data using statistical and analytical tools to drive data-based decision-making.
• Prepare and update Standard Operating Procedures (SOPs).
• Execute equipment installation and operational qualifications, validation protocols, reports, and change controls.
• Support technical services by troubleshooting activities in the operation department.
• Review and develop process protocols.
• Generate reports, charts, and tables based on established statistical methods to drive process enhancements.
• Investigate process deviations and non-conformances.
• Perform Root Cause Analysis (RCA) and support CAPA implementation.
• Evaluate, improve, and validate current manufacturing practices, processes, and equipment with an effort for continuous improvement towards productivity, quality, reliability, and consistency.
• Provide support on manufacturing/engineering equipment uptime.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards.
• Collaborate with cross-functional teams to support continuous improvement initiatives and regulatory readiness.
• Communicate with vendors on the possibility of material improvement.
• Write deviation and CAPA (Corrective action and preventive action) reports.

Requirements & Tech Stack

• Engineering
• Pharmaceutics
• Industrial Pharmacy
• Pharmaceutical Manufacturing
• Process Simulations
• Statistical Tools
• Analytical Tools
• Equipment Validation
• FDA Regulations
• cGMP Requirements
• Root Cause Analysis (RCA)
• CAPA (Corrective Action and Preventive Action)

Qualifications

• Bachelor's Degree (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or a related field - Required.
• Master's Degree (MS/MA) in Engineering, Pharmaceutics, Industrial Pharmacy, or a related field - Preferred.