Process Engineer

engineeringjobs.net, Inc.; Franklin (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

engineeringjobs.net, Inc. is seeking a Process Engineer to support daily manufacturing operations with a focus on reliable processes.

The role covers fermentation, drying, milling, and blending, aiming to resolve production issues and improve process performance. Responsibilities include monitoring critical parameters, analyzing data, leading CAPA investigations, and updating SOPs and batch records to ensure GMP-compliant operations.

Qualifications

• BS in Chemical Engineering, Biotechnology, Biochemical Engineering or related field.
• 3–5 years of experience in chemical processing, biotechnology, fermentation, food manufacturing, pharmaceutical, or related engineering environments.
• Hands-on experience with bioreactors, centrifuges, freeze dryers, or similar manufacturing equipment.

Responsibilities

• Provide day-to-day process engineering support for fermentation, drying, milling, and blending operations.
• Monitor critical process parameters and respond to performance or product quality issues.
• Analyze process data to establish baselines, identify variation sources, troubleshoot losses, and recommend improvements to increase yield and efficiency.
• Develop and maintain process specs, SOPs, work instructions, and batch support documentation to ensure safe, repeatable GMP manufacturing.

Skills

Fermentation

Scale-up

Troubleshooting

Data analysis

Documentation

Education

BS in Chemical Engineering

Biotechnology/Biochemical Eng degree

Tools

Bioreactors

Centrifuges

Freeze dryers

Process validation

Job description

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

Key Responsibilities

• 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
• 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
• Develop update and maintain process specifications SOPs work instructions engineering standards and batch support documentation to ensure safe repeatable and compliant manufacturing operations
• 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
• 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
• 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
• 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
• 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
• Follow all company safety quality food safety and regulatory procedures
• Perform other related tasks and responsibilities as assigned

Additional Responsibilities

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

Work Environment

Work Environment Work is performed primarily in a fermentation production facility laboratory and manufacturing support environmentThe role may include frequent exposure to wet humid dusty and noisy conditionsMay be exposed to airborne particles and chemicals used in fermentation production facilitiesRequires use of company issued uniform and required Personal Protective Equipment

Minimum Qualifications

• BS in Chemical Engineering Biotechnology Biochemical Engineering or a related technical field3 5 years experience within chemical processing biotechnology fermentation food manufacturing pharmaceutical or related engineering environments
• Hands on experience with bioreactors centrifuges freeze dryers spray dryers or similar manufacturing equipment preferred
• Working knowledge of batch fed batch and continuous fermentation preferred
• Experience supporting process scale up troubleshooting technology transfer or manufacturing process improvement
• Ability to analyze process data identify trends and communicate technical recommendations clearly

Preferred Qualifications

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

Technical Skills

• Fermentation process scale up and optimization
• Bioreactor operation and control strategy development
• Freeze drying spray drying and downstream processing knowledge
• Process troubleshooting and root cause analysis
• Data analysis technical reporting and process documentation
• SOP batch record and manufacturing documentation support
• Equipment commissioning validation qualification and start up support

Non Technical Skills

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

Licenses Certifications

• No specific license or certification required
• Lean Six Sigma GMP food safety or related technical certifications preferred

Physical & Safety Requirements

• Mandated use of company issued uniform and Personal Protective Equipment
• Adherence to all company safety procedures and regulations to maintain a safe working environment
• Majority of work is conducted in a fermentation production facility and includes frequent exposure to wet humid dusty and noisy conditions
• Work includes lifting up to 50 lbs standing walking as well as occasional scooping kneeling or crouching
• 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