Facilities Engineer
Illumina
Summary
The Facilities Engineer will be responsible for developing and executing validation protocols as related to new or upgraded facilities and utilities as used for medical device manufacturing. This person will work cross-functionally to assist with the development of requirements based on their expertise in clean rooms, water systems, HVAC and other systems used to support a regulated manufacturing environment. This person will also be responsible for report writing.
Job description
Position Summary
The Facilities Engineer will be responsible for developing and executing validation protocols as related to new or upgraded facilities and utilities as used for medical device manufacturing. This person will work cross-functionally to assist with the development of requirements based on their expertise in clean rooms, water systems, HVAC and other systems used to support a regulated manufacturing environment. This person will also be responsible for report writing.
Responsibilities
- Work cross functionally to develop and execute validation plans
- Generation of design specifications as well as other engineering-related documentation to support facility / utility qualifications and commissioning
- Preparation and execution of protocols for validation of HVAC, environmental monitoring, utilities, clean rooms, and cold storage
- Develop and defend rationale for protocol design, sampling requirement, and acceptance criteria using industry accepted standards
- Compile and analyze validation data and prepare reports
- Investigate and troubleshoot problems which occur during qualification and determine solutions
- Assess impact of change control to qualified systems to ensure a state of compliance is maintained
- Develop and coordinate schedules in conjunction with the other functional groups and vendors
- Lead continuous improvement and sustaining efforts to improve effectiveness of validation procedures
- Requirement for excellent communication skills and the 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 for medical device manufacturing.
- Establish and maintain cross functional relationships with manufacturing, engineering, quality control, development and regulatory for validation optimization and support of a successful facility validation program.
- Experience with sustaining and validation of environmental monitoring and control systems (BMS / EMS)
- Ability to manage competing priorities/projects and maintain tight timelines
Requirements
- 2+ years of experience in Facilities/HVAC/utilities systems for a medical device of pharmaceutical company
- 2+ years of experience writing or executing validations
- Experience commissioning or validating a new facility is desired
- Experience working directly with the FDA is desired
- Must be a highly motivated leader ready to work in a fast-paced environment.
Requirements
- 2+ years of experience in Facilities/HVAC/utilities systems for a medical device or pharmaceutical company
- 2+ years of experience writing or executing validations
- Experience commissioning or validating a new facility is desired
- Experience working directly with the FDA is desired
- Must be a highly motivated leader ready to work in a fast-paced environment
Benefits
- Genomics sequencing
- Family planning
- Health insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Paid time off
- Bonus program
- Commission program
- Equity
Company overview
Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.