Facilities Engineer

Illumina•Madison, WI

25d•$69,400 - $104,200

About The Position

The Facilities Engineer develops and executes validation protocols for new or upgraded facilities and utilities used in medical device manufacturing. The role applies expertise in clean rooms, water systems, HVAC, and other systems that support regulated manufacturing. It works cross-functionally to develop requirements, qualify facilities and utilities, maintain compliance, and prepare validation reports. The Facilities Engineer also coordinates schedules with functional groups and vendors, troubleshoots qualification issues, assesses the impact of changes to qualified systems, and leads continuous improvement and sustaining efforts. The role requires strong communication and the ability to build relationships across manufacturing, engineering, quality control, development, and regulatory teams. The position is not eligible for visa sponsorship.

Requirements

At least 2 years of experience with facilities, HVAC, or utility systems in a medical device or pharmaceutical company.
At least 2 years of experience writing or executing validations.
Foundational understanding and practical experience with FDA cGMP regulations and requirements for facilities and utilities used in medical device manufacturing.
Excellent communication skills and the ability to interact with cross-functional groups at all levels.
Ability to manage competing priorities and projects and maintain tight timelines.
Highly motivated leader able to work in a fast-paced environment.

Nice To Haves

Experience commissioning or validating a new facility.
Experience working directly with the FDA.

Responsibilities

Work cross-functionally to develop and execute validation plans.
Generate design specifications and other engineering documentation to support facility and utility qualifications and commissioning.
Prepare and execute protocols for validation of HVAC, environmental monitoring, utilities, clean rooms, and cold storage.
Develop and defend the rationale for protocol design, sampling requirements, and acceptance criteria using industry-accepted standards.
Compile and analyze validation data and prepare reports.
Investigate and troubleshoot problems arising during qualification and determine solutions.
Assess the impact of change control on qualified systems to ensure compliance is maintained.
Develop and coordinate schedules with other functional groups and vendors.
Lead continuous improvement and sustaining efforts to improve the effectiveness of validation procedures.
Establish and maintain cross-functional relationships with manufacturing, engineering, quality control, development, and regulatory teams to optimize validation and support the facility validation program.
Sustain and validate environmental monitoring and control systems (BMS/EMS).
Manage competing priorities and projects while maintaining tight timelines.