Facilities Engineer

Illumina • Madison, WI

22h

About The Position

The Facilities Engineer develops and executes validation protocols for new or upgraded facilities and utilities supporting medical device manufacturing. The role applies expertise in clean rooms, water systems, HVAC, and other systems used in regulated manufacturing environments, and includes report writing. The engineer works cross-functionally to establish requirements, qualify and commission facilities and utilities, maintain compliance of qualified systems, and support an effective facility validation program.

Requirements

• At least 2 years of experience with facilities, HVAC, or utility systems at a medical device or pharmaceutical company.
• At least 2 years of experience writing or executing validations.
• Excellent communication skills and ability to interact with cross-functional groups at all levels.
• Foundational understanding and practical experience with FDA cGMP regulations and requirements for facilities and utilities in medical device manufacturing.
• Experience sustaining and validating environmental monitoring and control systems (BMS/EMS).
• Ability to manage competing priorities and projects while maintaining tight timelines.
• Highly motivated leader ready 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 supporting 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 protocol design rationale, sampling requirements, and acceptance criteria using industry-accepted standards.
• Compile and analyze validation data and prepare reports.
• Investigate and troubleshoot qualification problems and determine solutions.
• Assess the impact of change control on qualified systems to ensure continued compliance.
• Develop and coordinate schedules with other functional groups and vendors.
• Lead continuous improvement and sustaining efforts to improve validation procedures.
• Establish and maintain cross-functional relationships with manufacturing, engineering, quality control, development, and regulatory groups to optimize validation and support the facility validation program.

Benefits

• Access to genomics sequencing.
• Family planning benefits.
• Health, dental, and vision benefits.
• Retirement benefits.
• Paid time off.
• Variable cash program (bonus or commission).
• Equity may be included for eligible roles.
• Employee Resource Groups offering career development experiences, cultural awareness, and social responsibility opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed