Job DescriptionProcess Engineer - API Manufacturing RemediationLocation: Greater Madison Area, WI
Duration: Minimum 6-month on-site project assignment
Position Type: Full-time consulting assignment
Position OverviewAutomated Systems, Inc. is seeking a Process Engineer for a minimum 6-month on-site consulting assignment with an API manufacturer in the Greater Madison Area, Wisconsin. This role will support remediation and manufacturing improvement efforts at a biologically derived API site producing enzymes. The site also supports broader recovery and purification capabilities used in natural-product and biopharmaceutical processing.
The selected engineer will work directly with manufacturing and quality teams on organ/raw-material receiving and initial processing, API-contact equipment condition, wet-cake handling and storage, drying operations, solvent-based extraction steps, precipitation, centrifugation, filtration, ultrafiltration, reverse osmosis, chromatography, and related remediation activities.
Key Responsibilities- Serveas a process and remediation engineer supporting API manufacturingoperations, technical problem-solving, and quality-system improvementinitiatives.
- Partnerwith Manufacturing, Quality, Validation, Technical Services, Regulatory,and site leadership to investigate deviations, OOS results, complaints,and process failures, and help ensure appropriate technicalfollow-through.
- Leador support root-cause investigations using sound engineering andquality-risk-management principles; ensure investigations are data-driven,well-scoped, and extended appropriately to related lots, materials,processes, and systems where warranted.
- Evaluateprocess equipment, materials of construction, contact surfaces, andmaintenance practices to improve suitability for CGMP manufacturing andreduce contamination risk.
- Supportimplementation of preventive maintenance, inspection, equipmentmonitoring, repair follow-up, and lifecycle improvements for manufacturingequipment and supporting infrastructure.
- Planand execute studies, trials, and technical evaluations in support ofprocess improvements, CAPAs, validation activities, and manufacturingreadiness.
- Developand revise technical documents such as protocols, reports, assessments,engineering justifications, operating procedures, scope documents, changecontrols, and remediation action plans.
- Providetechnical support for batch-impact assessments, retain-sample evaluations,and risk assessments associated with manufacturing events orequipment-related concerns.
- Helpstrengthen contamination-control practices for animal-derived APIoperations, including practical controls for process variability, holddecisions, escalation, and disposition support.
- Coordinatecontractors, technicians, validation resources, and cross-functionalcontributors as needed to execute projects and remediation tasks.
- Identifyopportunities to improve methods, systems, and operating discipline, andhelp convert those improvements into standard practice.
RequirementsQualifications- Bachelor'sdegree in Chemical Engineering, Mechanical Engineering, BiomedicalEngineering, Industrial Engineering, or a related technical discipline.
- Engineeringexperience in a pharmaceutical, biotech, API, medical device, food, orsimilarly regulated manufacturing environment.
- Abilityto analyze process, equipment, and quality data; identify key factors; andrecommend practical corrective actions.
- Interpersonalskills to negotiate priorities, reconcile differences, and maintainmomentum in a cross-functional environment.
- Abilityto work independently, manage multiple assignments, and drive issues toclosure without excessive direction.
- Comfortableoperating in a fast-paced project environment with shifting priorities andsignificant visibility.
