Hybrid Facilities Engineer 1 presso Illumina

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At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

The Facilities Engineer 1 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

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:

• Typically Requires a minimum of 0-2 years of related experience with a bachelor’s degree or technical schooling; or a master’s degree; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls.

• Some knowledge of clean rooms, RODI, HVAC and other systems used to support a regulated manufacturing environment

• Experience creating master validation plans, protocols, and reports

• Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook

• Ability to read construction drawings and blueprints

• Demonstrated analytical and problem-solving skills

• Strong oral and written communication skills

• Good design, research, writing and verbal communication skills.

• All other duties assigned as required.

The estimated base salary range for the Facilities Engineer 1 role based in the United States of America is: $61,700 - $92,500. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. 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.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. 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. Candidarsi ora