Process Engineer

The Process Engineer position is responsible for supporting daily manufacturing operations, with a focus on maintaining reliable processes, resolving production issues and improving process performance across fermentation, drying, milling and blending. The position will collaborate with Manufacturing, Quality Control, Research & Development, Engineering, Maintenance and other cross-functional teams to troubleshoot process issues, improve production yields, support equipment reliability and enhance overall process performance. The role will also support equipment commissioning, technology transfer, process validation, process monitoring and other continuous improvement initiatives.

Key Responsibilities

1. Provide day-to-day process engineering support for fermentation, freeze-drying, spray-drying, milling and blending operations. Monitor critical process parameters and respond to emerging performance or product-quality issues.
2. Analyze process and production data to establish operating baselines, identify sources of variation, troubleshoot losses and recommend improvements that increase yield, capacity, consistency and efficiency.
3. Develop, update and maintain process specifications, SOPs, work instructions, engineering standards and batch-support documentation to ensure safe, repeatable, and compliant manufacturing operations.
4. Lead or support investigations into process deviations, equipment failures, and performance gaps. Apply structured root cause analysis and implement corrective and preventive actions with cross-functional partners.
5. Support process scale-up, technology transfer and capital projects from design through start-up, including equipment selection, process risk assessments, commissioning, qualification and execution of engineering studies and protocols.
6. Ensure process changes and engineering activities comply with applicable GMP, HACCP, food safety, quality, environmental and occupational safety requirements, including required change-control and validation practices.
7. Collaborate with Manufacturing, Quality, Maintenance, Engineering and R&D to resolve technical issues, improve equipment reliability, reduce downtime and waste, and deliver operational and continuous-improvement objectives.
8. Prepare clear, accurate, and traceable technical documentation, including engineering reports, process assessments, project updates, and recommendations. Communicate findings, risks, and actions to stakeholders and management.
9. Follow all company safety, quality, food safety and regulatory procedures.
10. Perform other related tasks and responsibilities, as assigned.

Additional Responsibilities

1. Participate in cross-functional project teams supporting process changes, manufacturing improvements and new product introductions.
2. Support training of manufacturing personnel on new or revised processes, procedures and equipment as needed.
3. Maintain accurate technical records, reports, and documentation in accordance with company requirements.

Work Environment

1. Work is performed primarily in a fermentation production facility, laboratory, and manufacturing support environment.
2. The role may include frequent exposure to wet, humid, dusty, and noisy conditions.
3. May be exposed to airborne particles and chemicals used in fermentation production facilities.
4. Requires use of company-issued uniform and required Personal Protective Equipment.

Minimum Qualifications

1. B.S. in Chemical Engineering, Biotechnology, Biochemical Engineering, or a related technical field.
2. 3 - 5 years+ experience within chemical processing, biotechnology, fermentation, food manufacturing, pharmaceutical, or related engineering environments.
3. Hands-on experience with bioreactors, centrifuges, freeze dryers, spray dryers, or similar manufacturing equipment preferred.
4. Working knowledge of batch, fed-batch and continuous fermentation preferred.
5. Experience supporting process scale-up, troubleshooting, technology transfer or manufacturing process improvement.
6. Ability to analyze process data, identify trends and communicate technical recommendations clearly.

Preferred Qualifications

1. Experience in FDA-regulated, food safety, biotechnology, pharmaceutical, or GMP manufacturing environments.
2. Experience supporting equipment commissioning, validation, qualification, or manufacturing start-up activities.
3. Experience developing or revising SOPs, batch records, process control strategies or technical reports.
4. Knowledge of root cause analysis, corrective and preventive actions, statistical analysis, or continuous improvement methodologies.
5. Advanced degree in Chemical Engineering, Biotechnology, Biochemical Engineering, or a related discipline.

Technical Skills

1. Fermentation process scale-up and optimization.
2. Bioreactor operation and control strategy development.
3. Freeze drying, spray drying, and downstream processing knowledge.
4. Process troubleshooting and root cause analysis.
5. Data analysis, technical reporting, and process documentation.
6. SOP, batch record, and manufacturing documentation support.
7. Equipment commissioning, validation, qualification, and start-up support.

Non-Technical Skills

1. Strong analytical and problem-solving skills.
2. Effective written and verbal communication skills.
3. Ability to collaborate across Manufacturing, Quality, Research & Development, Engineering, and other departments.
4. Strong attention to detail and commitment to documentation accuracy.
5. Ability to manage multiple priorities in a fast-paced manufacturing environment.
6. Continuous improvement mindset.
7. Sound judgment and ability to make practical, data-based recommendations.

Licenses/Certifications

1. No specific license or certification required.
2. Lean Six Sigma, GMP, food safety, or related technical certifications preferred.

Physical & Safety Requirements

1. Mandated use of company-issued uniform and Personal Protective Equipment.
2. Adherence to all company safety procedures and regulations to maintain a safe working environment.
3. Majority of work is conducted in a fermentation production facility and includes frequent exposure to wet, humid, dusty, and noisy conditions.
4. Work includes lifting up to 50 lbs., standing, walking, as well as occasional scooping, kneeling, or crouching.
5. May be exposed to airborne particles and chemicals used in fermentation production facilities.

Disclaimer

Adherence to all food safety procedures as per FDA regulations, including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal, state, or local food safety regulations.