Process Engineer

Bimeda•Pomona, CA

25d•$90,000 - $110,000•Onsite

About The Position

The Process Engineer provides technical leadership throughout 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 consistently deliver high-quality products. Serving as a technical subject matter expert, the Process 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 anticipates technical risks and translates process knowledge into practical solutions that improve manufacturing performance, product quality, and business outcomes. The position is based in-office in Pomona, California, with work in warehouse and production environments. These environments may involve noise, chemicals, and machinery; PPE is required in certain areas. The role may require work outside regular hours or on weekends and includes walking, standing, and occasional lifting of up to 50 pounds.

Requirements

Bachelor’s degree in Chemical Engineering and 4 or more 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 and 2 or more 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 (QbD), 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.
Demonstrated 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 communication, including clear verbal and business writing, active listening, adapting communication to the audience, and communicating with data and facts.
Ability to foster collaboration and teamwork, build partnerships, and work cooperatively with others.
Analytical thinking and problem-solving skills, including gathering information, identifying key components, recognizing patterns and trends, and supporting data-driven decisions.
Initiative, including identifying what needs to be done and acting before being asked or before circumstances require it.

Responsibilities

Lead and execute technology transfers for commercial pharmaceutical products, including developing 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 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, and identify and resolve 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, OOS 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 qualification and implementation of a transfer pump for transferring 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 for assigned processes 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 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.
Take on other relevant duties commensurate with the role as duties, priorities, and requirements evolve.