Production & Process Engineering

Job Title: Process Engineer
Location: Pomona, CA (In-office)
Position Type: Full-time
AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants Job Summary
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.
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.
Process Design, Risk Management and Compliance

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.

Equipment and Process Improvement

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 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 sources of 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 to the organization.
Serve as a technical subject matter expert for assigned processes and build strong 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 through data, scientific rationale, and sound engineering judgment.
Mentor and develop junior engineers and contribute to building a culture of technical excellence, process ownership, and continuous improvement.
Working conditions: warehouse and production environments. Exposure to noise, chemicals, and machinery. May require work outside regular hours or weekends.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Express oneself clearly in verbal and business writing.
Builds partnerships for global performance. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this, supporting data-driven decision-making and strategic planning.
Bachelor’s degree in Chemical Engineering with 4+ years of relevant experience in process engineering, process design, technology transfer, or validation within pharmaceutical manufacturing; Master’s degree in Engineering or a related discipline with 2+ years of relevant experience.
Experience in pharmaceutical manufacturing, preferably within 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.
Ability to interpret process data and translate technical findings into practical manufacturing and business decisions.
Ability to manage multiple projects and priorities while meeting deadlines in a fast-paced manufacturing environment.
Health Insurance (medical, dental, vision)

• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across six countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity or expression, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other basis protected by applicable federal, state, or local law.
We value diverse perspectives and encourage applications from people of all backgrounds, experiences, and abilities. If you need a reasonable accommodation to participate in the application or interview process, please contact us at hr.