Facilities Systems Engineer II - GMP & Compliance

Abbott (abbottcareers2 board); United States; On-site; USD 85,000 - 115,000; Full time

Job summary

Abbott is a global healthcare leader seeking a Manufacturing Facilities Engineer II for its Infectious Disease Developed Markets unit in Scarborough, Maine. The role focuses on maintaining facilities systems, driving approved changes, and delivering mid-scale projects in a regulated manufacturing environment.

You will troubleshoot, improve processes and facilities, and collaborate with engineering, technicians, production staff, quality, and operations to meet timelines and regulatory

Responsibilities

• Ensures compliance with local, state, and federal agencies.
• Manages and completes QMS actions related to facility processes and equipment.
• Enforces safety protocols for staff and contractors on projects.
• Coordinates with other departments to meet project timelines.
• Owns critical facilities systems and ensures performance, compliance, and reliability.
• Leads root cause investigations and drives corrective/preventive actions.
• Develops and maintains facilities standards, SOPs, and design docs.
• Reviews drawings, calculations, validation docs and change impacts for regulatory compliance.
• Serves as primary technical interface with vendors/contractors for assigned systems.
• Leads medium-scale facilities projects and system upgrades with cross-functional teams.
• Supports commissioning and validation activities, including test strategy and data analysis.
• Evaluates existing systems for process suitability, capacity, and risk; develops improvement plans.
• Manages change control activities through Agile PLM or equivalent systems.
• Provides technical guidance and mentorship to junior Facilities Engineers and Technicians.
• Participates in audits and inspections as a system SME.
• Complies with FDA regulations, ISO, and other regulatory requirements and company policies.
• Maintains positive, cooperative communications across all levels of staff, customers, contractors, and vendors.

Job description

Abbott is a global healthcare leader seeking a Manufacturing Facilities Engineer II for its Infectious Disease Developed Markets unit in Scarborough, Maine. The role focuses on maintaining facilities systems, driving approved changes, and delivering mid-scale projects in a regulated manufacturing environment.

You will troubleshoot, improve processes and facilities, and collaborate with engineering, technicians, production staff, quality, and operations to meet timelines and regulatory