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
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
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.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
The estimated base salary range for the Facilities Engineer role based in the United States of America is: $69,400 - $104,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
