Engineer - F&E Environmental & Contamination Control

Career Category

Operations

Engineer, F&E Environmental & Contamination Control

What you will do

In this vital role you will report to the Facilities & Engineering organization and serve as a technical deviation owner or functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events. The Engineering Deviation Owner and/or functional area owner is accountable for the end-to-end management of assigned deviation records, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed in accordance with site procedures and regulatory expectations.

• Demonstrated technical writer capable of translating complex engineering, equipment, automation, utility, and project-related events into concise, technically accurate, and inspection-ready documentation.
• Independently drive deviation investigations from initiation through closure while ensuring compliance with site procedures and quality system requirements.
• Maintain accountability for record quality, data integrity, technical accuracy, and timely progression of assigned deviations.
• Prioritize and manage multiple investigations simultaneously in a dynamic manufacturing environment.

• Develop and execute investigation strategies for equipment, utility, facility, automation, commissioning, qualification, and manufacturing support events.
• Conduct field assessments, equipment walkdowns, system reviews, and Genba activities to gather factual evidence.
• Utilize engineering problem-solving methodologies to determine root cause and contributing factors.
• Lead structured Root Cause Analysis (RCA) sessions involving cross‑functional stakeholders.
• Evaluate potential impacts on validated systems, product quality, operational reliability, and compliance.

• Develop technically robust corrective and preventive actions aligned with investigation outcomes.
• Ensure CAPAs address both immediate causes and systemic contributors.
• Support effectiveness verification activities and long‑term monitoring strategies.
• Identify opportunities to improve equipment reliability, utility performance, maintenance practices, and engineering processes.

• Partner with Manufacturing, Quality Assurance, Quality Control, Automation, Maintenance, Facilities, Engineering Technical Authorities (ETA), Process Development, Capital Projects, and Global Engineering organizations.
• Facilitate alignment among stakeholders and drive timely technical decision‑making.
• Ensure appropriate SME engagement and challenge assumptions through data‑driven discussions.

• Develop investigation narratives and technical assessments that clearly communicate event chronology, causal analysis, risk assessments, and conclusions.
• Support impact assessments associated with equipment modifications, utility system changes, automation updates, commissioning and qualification activities, and capital project implementation.
• Ensure documentation meets Quality Management System (QMS) requirements and inspection expectations.

• Serve as a Subject Matter Expert (SME) during regulatory inspections and internal audits for assigned investigations.
• Defend technical conclusions, investigation rationale, and risk‑based decisions.
• Support inspection preparation activities and response development as needed.

• Analyze deviation trends associated with equipment reliability, utility performance, automation systems, facility infrastructure, commissioning and qualification activities.
• Identify recurring issues and opportunities for systemic improvement.
• Leverage digital tools, data analytics, AI‑enabled technologies, and engineering metrics to improve investigation efficiency and effectiveness.
• Contribute to site initiatives focused on reliability, operational excellence, and inspection readiness.

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