Process Engineer - API Manufacturing Remediation

Process Engineer – API Manufacturing Remediation

Location: Greater Madison, WI area
Duration: Minimum 6-month on-site project assignment
Position Type: Full-time consulting assignment

Position Overview

Automated Systems, Inc. is seeking a Process Engineer for a minimum 6-month on-site consulting assignment with an API manufacturer in the greater Madison, Wisconsin area. 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

• Serve as a process and remediation engineer supporting API manufacturing operations, technical problem-solving, and quality-system improvement initiatives.
• Partner with Manufacturing, Quality, Validation, Technical Services, Regulatory, and site leadership to investigate deviations, OOS results, complaints, and process failures, and help ensure appropriate technical follow-through.
• Lead or support root-cause investigations using sound engineering and quality-risk-management principles; ensure investigations are data-driven, well-scoped, and extended appropriately to related lots, materials, processes, and systems where warranted.
• Evaluate process equipment, materials of construction, contact surfaces, and maintenance practices to improve suitability for CGMP manufacturing and reduce contamination risk.
• Support implementation of preventive maintenance, inspection, equipment monitoring, repair follow-up, and lifecycle improvements for manufacturing equipment and supporting infrastructure.
• Plan and execute studies, trials, and technical evaluations in support of process improvements, CAPAs, validation activities, and manufacturing readiness.
• Develop and revise technical documents such as protocols, reports, assessments, engineering justifications, operating procedures, scope documents, change controls, and remediation action plans.
• Provide technical support for batch-impact assessments, retain-sample evaluations, and risk assessments associated with manufacturing events or equipment-related concerns.
• Help strengthen contamination-control practices for animal-derived API operations, including practical controls for process variability, hold decisions, escalation, and disposition support.
• Coordinate contractors, technicians, validation resources, and cross-functional contributors as needed to execute projects and remediation tasks.
• Identify opportunities to improve methods, systems, and operating discipline, and help convert those improvements into standard practice.

Qualifications

• Bachelor’s degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related technical discipline.
• Engineering experience in a pharmaceutical, biotech, API, medical device, food, or similarly regulated manufacturing environment.
• Ability to analyze process, equipment, and quality data; identify key factors; and recommend practical corrective actions.
• Interpersonal skills to negotiate priorities, reconcile differences, and maintain momentum in a cross-functional environment.
• Ability to work independently, manage multiple assignments, and drive issues to closure without excessive direction.
• Comfortable operating in a fast-paced project environment with shifting priorities and significant visibility.