Process Engineer

Job Title:

Process Engineer

Location:

Pomona, CA (In-office)
Position Type:
Full-time
Vacancy Status:
This position is vacant
AI Disclosure in Hiring:
We use artificial intelligence to screen, assess and select applicants

The Process Engineer plays a critical role in the successful development, transfer, validation, and ongoing performance of pharmaceutical manufacturing processes. Reporting to the Validation Director, this position provides technical leadership across the product and process lifecycle, partnering closely with production, quality, validation, engineering, and other cross-functional teams to ensure processes are robust, scalable, compliant, and capable of consistently delivering high-quality products.

This role serves as a technical subject matter expert and thought leader, applying chemical engineering principles, Quality by Design (QbD), scientific understanding, and data-driven problem solving to improve process capability, reduce manufacturing risk, and support reliable commercial supply. The successful candidate will challenge the status quo, anticipate technical risks, and translate process knowledge into practical solutions that improve manufacturing performance, product quality, and business outcomes.

• Lead and execute technology transfer activities for commercial pharmaceutical products, including development of technology transfer protocols, reports, engineering batch protocols, and equipment compatibility assessments.
• Coordinate pilot, engineering, and validation batches with production, quality, validation, engineering, and other cross-functional teams.
• Develop and refine process flow diagrams, compounding instructions, and other technical documentation required to support commercial manufacturing.
• Apply process understanding and QbD principles to ensure processes are scalable, reproducible, and capable of consistently meeting quality and manufacturing requirements.
• Monitor process performance during scale-up and transfer activities and identify and resolve technical issues and process risks.

• Develop and execute process validation protocols and reports and support ongoing process verification activities.
• Evaluate critical process parameters (CPPs), critical quality attributes (CQAs), and process performance data to assess process capability, robustness, and variability.
• Conduct or support laboratory, pilot, engineering, and validation batches to generate process knowledge and support technical and regulatory requirements.
• Use statistical analysis, process monitoring, and trending to identify emerging risks and opportunities to improve process control and performance.

• Design and optimize manufacturing processes using sound chemical engineering principles and QbD methodology.
• Conduct process risk assessments, including FMEA, and develop appropriate risk mitigation strategies.
• Provide technical leadership for deviations, OOS investigations, root cause analysis, CAPAs, and Change Controls.
• Review production batch records and manufacturing documentation to ensure alignment with approved process design and technical requirements.
• Ensure process activities and recommendations comply with applicable GMP and regulatory requirements.

• Identify and lead opportunities to improve process robustness, manufacturing efficiency, product quality, yield, and reliability.
• Support the selection, acquisition, qualification, and implementation of new production equipment and technologies.
• Lead or support equipment and process improvement initiatives, including the qualification and implementation of a new…