Sr. 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.

The Sr 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 and electrical 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.

Responsibilities:

• Ability to serve as the Subject Matter Expert (SME) for a variety of facilities equipment supporting manufacturing, critical business functions and administrative areas.

• Provides direct input into the CMMS, SAP/EAM, to ensure health of the asset throughout the lifecycle. Examples of input include onboarding equipment, uploading maintenance plans, task lists and key calibration parameters.

• Work closely with maintenance mechanics assisting in complex equipment breakdowns. Provides direct input to Siemens Desigo BMS/EMS system

• Inspects all work to assure compliance with plans and specifications. Ensures project documents are complete, current, and stored appropriately.

• Oversees performance of all trade contractors and reviews architectural and engineering drawings to ensure that all specifications and regulations are being followed.

• Provide reports and presentations on proposed projects and policies. Perform other duties as assigned.

• Maintain reliability systems and programs to improve uptime.

• Track and analyze historical data of operations and KPIs.

• Provide input for continuous improvement in the areas of facilities and engineering.

• Provide input and author SOPs, Validation Protocols, Deviations, CAPAs and other GMP documentation.

• Generation of specifications and other engineering documents as used for equipment design and qualification.

• Provide input on procedures for equipment maintenance and calibration.

• Analysis of equipment metrics to support continuous improvement efforts.

• Support of engineering change control for new equipment design and modification.

• Creation of impact assessments for equipment changes.

• Support of internal processes to ensure regulatory compliance is maintained.

• Daily operational support as needed.

• Cross-functional collaboration to complete projects and solve problems.

• Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels.

• Ability to manage competing priorities and maintain tight timelines.

Requirements:

• Typically Requires a minimum of 5 years of related experience with a bachelor’s degree or technical schooling; or 3 years and a master’s degree; or a PhD without experience; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls.

• 5 years Equipment/Facilities Engineering experience, with design and/or maintenance focus

• Ideal candidate will have professional knowledge with Siemens BMS Desigo CC Master Operator, HMI

• 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