Engineer - F&E Environmental & Contamination Control

About the role

The Engineer, F&E Environmental & Contamination Control plays a crucial role in the Facilities & Engineering organization. They are responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events. This individual must demonstrate technical writing capabilities, independence in driving investigations, and the ability to prioritize and manage multiple investigations simultaneously.

Responsibilities

• 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.
• 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 to validated systems, product quality, operational reliability, and compliance.
• Develop technically robust corrective and preventive actions aligned with investigation outcomes.
• 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.
• 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.

Qualifications

• High school diploma/GED and 8 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR
• Associate's degree and 6 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR
• Bachelor's degree and 2 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR
• Master's degree
• BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related discipline
• 4+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
• Experience with: Facilities & Engineering systems, Equipment troubleshooting, Utility systems, Automation systems (DeltaV, BAS, PI), Commissioning & Qualification (C&Q), Root Cause Analysis methodologies, Change Control and Quality Systems
• Strong technical writing and analytical problem-solving skills
• Ability to influence and lead cross-functional teams without direct authority
• Experience applying AI, analytics, or digital tools to support investigations and continuous improvement