Process Engineer

Bimeda•Pomona, CA

23d•Onsite

About The Position

The Process Engineer provides technical leadership across the development, transfer, validation, and ongoing performance of pharmaceutical manufacturing processes. Reporting to the Validation Director, the role partners 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. The engineer applies 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 role leads technology transfer and scale-up, process validation and lifecycle management, process design and risk management, and manufacturing equipment and process improvement. It serves as a technical subject matter expert for assigned processes, identifies risks and improvement opportunities, supports investigations and regulatory compliance, and mentors junior engineers. The position is based in an office in Pomona, California, with work in warehouse and production environments. Those environments may involve noise, chemicals, and machinery, and PPE is required in certain areas. The role may require work outside regular hours or on weekends.

Requirements

Bachelor’s degree in Chemical Engineering with at least 4 years of relevant experience in process engineering, process design, technology transfer, or validation within pharmaceutical manufacturing; or a Master’s degree in Engineering or a related discipline with at least 2 years of relevant experience.
Experience in pharmaceutical manufacturing, preferably in a GMP-regulated environment.
Experience with technology transfer, process design, scale-up, process validation, and continuous process improvement.
Experience with solid and/or semi-solid pharmaceutical manufacturing, including powders, pastes, and suspensions.
Experience applying Quality by Design, process risk assessment, and statistical approaches to manufacturing processes.
Strong knowledge of pharmaceutical manufacturing processes and applicable FDA, EMA, and other regulatory requirements.
Proficiency in process design, process validation protocol development, process risk assessment, and technical documentation.
Working knowledge of manufacturing equipment and systems, including mixing tanks, filling lines, autoclaves, incubators, and associated process equipment.
Familiarity with utility systems such as compressed air, vacuum, purified water, and WFI.
Strong analytical, problem-solving, and communication skills.
Ability to interpret process data and translate technical findings into practical manufacturing and business decisions.
Ability to lead technical initiatives, influence cross-functional teams, and work independently.
Ability to manage multiple projects and priorities while meeting deadlines in a fast-paced manufacturing environment.
Effective verbal and business-writing communication, active listening, and ability to adapt communication to the audience.
Ability to collaborate and work cooperatively with others on a team.
Ability to identify needed information, analyze information from multiple sources, recognize patterns and trends, and use a logical, systematic approach to problem solving.
Initiative in identifying and completing work before being asked or before a situation requires it.

Responsibilities

Lead and execute technology transfers for commercial pharmaceutical products, including preparing transfer protocols and 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 for commercial manufacturing.
Apply process understanding and QbD principles to ensure processes are scalable, reproducible, and capable of meeting quality and manufacturing requirements.
Monitor process performance during scale-up and transfer, identifying and resolving technical issues and process risks.
Develop and execute process validation protocols and reports and support ongoing process verification.
Evaluate critical process parameters, critical quality attributes, 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 chemical engineering principles and QbD methodology.
Conduct process risk assessments, including FMEA, and develop risk mitigation strategies.
Provide technical leadership for deviations, out-of-specification investigations, root cause analysis, CAPAs, and Change Controls.
Review production batch records and manufacturing documentation for 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 selection, acquisition, qualification, and implementation of production equipment and technologies.
Lead or support equipment and process improvement initiatives, including qualifying and implementing a new transfer pump for moving product from the compounding tank to the IMA filling machine holding tank.
Use process data, engineering principles, and structured problem solving to identify variability, reduce waste, and improve manufacturing performance.
Stay current with advances in pharmaceutical manufacturing, process engineering, and analytical approaches and apply relevant technologies and best practices.
Serve as a technical subject matter expert and build process understanding from development and technology transfer through commercial manufacturing.
Proactively identify technical risks and opportunities before they become manufacturing or quality issues.
Challenge existing processes and assumptions using data, scientific rationale, and sound engineering judgment.
Influence cross-functional teams through technical expertise, clear communication, and business judgment.
Mentor and develop junior engineers and contribute to technical excellence, process ownership, and continuous improvement.