Process Engineer

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 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 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 issuesAnalyze process and production data to establish operating baselines identify sources of variation troubleshoot losses and recommend improvements that increase yield capacity consistency and efficiencyDevelop update and maintain process specifications SOPs work instructions engineering standards and batch support documentation to ensure safe repeatable and compliant manufacturing operationsLead 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 partnersSupport 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 protocolsEnsure process changes and engineering activities comply with applicable GMP HACCP food safety quality environmental and occupational safety requirements including required change control and validation practicesCollaborate 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 objectivesPrepare clear accurate and traceable technical documentation including engineering reports process assessments project updates and recommendations Communicate findings risks and actions to stakeholders and managementFollow all company safety quality food safety and regulatory proceduresPerform other related tasks and responsibilities as assignedAdditional Responsibilities Participate in cross functional project teams supporting process changes manufacturing improvements and new product introductionsSupport training of manufacturing personnel on new or revised processes procedures and equipment as neededMaintain accurate technical records reports and documentation in accordance with company requirementsWork 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 EquipmentMinimum 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 environmentsHands on experience with bioreactors centrifuges freeze dryers spray dryers or similar manufacturing equipment preferredWorking knowledge of batch fed batch and continuous fermentation preferredExperience supporting process scale up troubleshooting technology transfer or manufacturing process improvementAbility to analyze process data identify trends and communicate technical recommendations clearlyPreferred Qualifications Experience in FDA regulated food safety biotechnology pharmaceutical or GMP manufacturing environmentsExperience supporting equipment commissioning validation qualification or manufacturing start up activitiesExperience developing or revising SOPs batch records process control strategies or technical reportsKnowledge of root cause analysis corrective and preventive actions statistical analysis or continuous improvement methodologiesAdvanced degree in Chemical Engineering Biotechnology Biochemical Engineering or a related disciplineTechnical Skills Fermentation process scale up and optimizationBioreactor operation and control strategy developmentFreeze drying spray drying and downstream processing knowledgeProcess troubleshooting and root cause analysisData analysis technical reporting and process documentationSOP batch record and manufacturing documentation supportEquipment commissioning validation qualification and start up supportNon Technical Skills Strong analytical and problem solving skillsEffective written and verbal communication skillsAbility to collaborate across Manufacturing Quality Research \& Development Engineering and other departmentsStrong attention to detail and commitment to documentation accuracyAbility to manage multiple priorities in a fast paced manufacturing environmentContinuous improvement mindsetSound judgment and ability to make practical data based recommendationsLicensesCertifications No specific license or certification requiredLean Six Sigma GMP food safety or related technical certifications preferredPhysical \& Safety Requirements Mandated use of company issued uniform and Personal Protective EquipmentAdherence to all company safety procedures and regulations to maintain a safe working environmentMajority of work is conducted in a fermentation production facility and includes frequent exposure to wet humid dusty and noisy conditionsWork includes lifting up to 50 lbs standing walking as well as occasional scooping kneeling or crouchingMay be exposed to airborne particles and chemicals used in fermentation production facilitiesDisclaimer 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