Facilities Engineer 1
Facilities Engineer 1
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$ 61700 - 92500
1 Vacancy
Job Description
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 crossfunctionally 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 engineeringrelated documentation to support facility / utility qualifications and commissioning
- Preparation and 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 crossfunctional 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 02 years of related experience with a bachelors degree or technical schooling; or a masters 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 wellversed with Microsoft Office products such as Word Excel and Outlook
Ability to read construction drawings and blueprints
Demonstrated analytical and problemsolving skills
Strong oral and written communication skills
Good design research writing and verbal communication skills.
All other duties assigned as required.
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 zeronet 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 To learn more visit: 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.
Employment Type
Full-Time
