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Process Engineer – API Manufacturing Remediation

Automated Systems

Greater Madison Area, Greater Madison Area

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JOB DETAILS
SKILLS
Active Pharmaceutical Ingredient (API), Animal Control, Application Programming Interface (API), Audio Engineering, Biomedical Engineering, Biotech and Pharmaceutical, Change Control, Chemical Engineering, Chromatography, Construction, Consulting, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Engineering, Equipment Maintenance/Repair, Follow Through, Industrial Engineering, Interpersonal Skills, Leadership, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Mechanical Engineering, Medical Equipment, Negotiation Skills, Operational Support, Operations Processes, Preventative Maintenance, Problem Solving Skills, Process Analysis, Process Engineering, Process Improvement, Regulations, Risk Analysis, Risk Management, Root Cause Analysis, Technical Analysis, Technical Operations, Technical Support, Technical Writing
LOCATION
Greater Madison Area, Greater Madison Area
POSTED
30+ days ago

Process Engineer – API Manufacturing Remediation

Location: Greater Madison Area, WI 
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 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

  • 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.


Requirements

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.

 



About the Company

A

Automated Systems

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