Staff Facilities Engineer

What if the work you did every day could impact the lives of people you know? Or all of humanity?

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.

Staff Facilities Engineer - US1


Summary

The Staff Facilities Engineer will be part of the San Diego Facilities Engineering team. This role will be responsible for providing technical expertise as related to mechanical, electrical and plumbing systems within facilities equipment engineering, support maintenance, and/or calibration and equipment performance optimization. Including projects related to mechanical, electrical, and plumbing (MEP) systems in an FDA regulated environment. The individual will possess technical knowledge of facilities water purification (RO/DI) skids, HVAC, chillers, centralized gas distribution systems, walk-in cold storage units, clean rooms, BMS/EMS system, Electrical generation and distribution system for Low, Medium and High Voltage, and other plant utilities, facilities validation, as well as construction management skills.

Key Responsibilities

- Responsible for facilities equipment Calibration and Lifecycle Asset Management (LCAM), mid-sized mechanical, electrical, and plumbing (MEP)

- Ability to serve as the Subject Matter Expert (SME) for a variety of facilities equipment supporting manufacturing, critical business functions and administrative areas and work cross functionally.
- Facilitate the generation of design specifications as well as other engineering-related documentation to support facility / utility qualifications and commissioning
- Work closely with maintenance team assisting in complex equipment breakdowns. Provides direct input to Siemens Desigo BMS and Vaisala EMS system

- Participate in facility renovations, construction, and infrastructure improvement projects, including managing external contractors.

- Perform Facilities Impact Assessment, change control activities and facilities validation to qualified systems to ensure a state of compliance is maintained all within an FDA regulated environment.

- Provide input and author SOPs, Work Instructions (WI), Validation Protocols, Deviations, CAPAs and other GMP documentation.
- Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels
- Deep level of 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 others

- Lead continuous improvement and sustaining efforts for products and processes in support of cost and performance objectives.
- Ability to manage competing priorities/projects and maintain tight timelines

- Participate in productive cross-site and cross-functional relationship between manufacturing sites.

- Daily operational support as needed

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

• Familiarity with related quality standards (ISO 13485, 21 CFR 820, etc.) for implementation and review.

• Understanding of a risk-based approach to Commissioning, Qualification and Validation (CQV) of Facilities, Utilities and Equipment (FUE) in a medical device and/or drug GMP environment Experience working cross-functionally to develop technical requirements

• Experience in clean rooms, RODI, HVAC and other systems used to support a regulated manufacturing environment

• Experience with Siemens building automated programs such as Insight or Desigo. Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook Must be able to read construction drawings and blueprints

• Strong understanding of the entire design, construction, and contracting processes

• Familiar with AutoCAD, Revit, and Bluebeam

• Familiar with CMMS, like SAP/EAM, Maximo,

• Demonstrated analytical and problem-solving skills