Sr. Facilities Engineer
Illumina
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
Experience creating master validation plans, protocols, and reports
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
Strong oral and written communication skills
Highly organized and detailed-oriented, with superior data analysis/synthesis skills, both quantitative and qualitative
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 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.