Engineer 2 - Compliance (Finance)

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.

Responsibilities:

• Owns and drives all manufacturing NCRs, CAPAs, and customer complaints within assigned value stream.
• Supports audit readiness and on-site audits.
• Strong personal communications skills to influence other departments and individuals.
• Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
• Establish and support best practices for problem solving, root cause analysis, and solution selection tools.
• Tracks KPIs related to health of quality systems
• Support projects across the Strategic Engineering team to support engineering, data analysis, technical writing, and training activities
• Provide necessary support to ensure GMP compliance and other regulatory requirements are maintained within production; oversee and verify critical steps and process as defined per manufacturing process and management
• In conjunction with Equipment Engineers, support manufacturing areas with their equipment lifecycle processes, investigation and root cause analysis
• Assist with the identification, creation and review of project plans initiatives and milestones, ensuring manufacturing, quality and regulatory requirements are met within established project timelines
• Assist with the identification, planning, and procurement of manufacturing related items (equipment and supporting materials) needed for the space
• Manage change controls for existing equipment lifecycle processes and documentation, including initiating and/or overseeing change control requests, coordinating timelines and appropriate delegation of activities to cross functional groups with respect to change control and ensuring all tasks are completed
• Drive continuous improvement initiatives as it relates to safety, quality, waste reduction, and production efficiency/capacity
• Provide ongoing technical and scientific support for manufacturing process improvements and new product and process transfers
• Accountable for identifying and implementing Good Manufacturing practices (GMP) to MFG areas
• Participate in Kaizen events as required
• Help implement improvement initiatives such as 5S and other lean manufacturing programs
• Develop and train new and existing personnel in GMP compliance and production procedures as applicable by their job responsibilities
• Some night shift and/or weekend work may be required

  Requirements:

• Experience in a production and/or product development preferred.
• Experience in a cGMP environment highly desired, in applying best work practices and techniques
• Must understand the process of control requirements for production and process improvement as per QSR, FDA, ISO 90001/13485, and other regulatory requirements
• Must understand the technical application of automation and other manufacturing and quality control testing processes, related metrics, and trending data management to drive continuous improvement
• Highly desirable to have experience and knowledge of operations of IVDs, medical devices, and/or Pharmaceutical products
• Highly desirable project management experience related to new construction or renovation projects of laboratory spaces
• Knowledge of Document Control systems, and ERP/MRP control systems (e.g JDE or SAP); highly desirable knowledge of electronic manufacturing batch management systems (e.g. Camstar)
• Must have the ability to adapt to rapidly changing priorities and has the flexibility to support operations in accordance with departmental and company schedules and priorities
• Excellent communication, interpersonal, and leadership skills
• Must be able to independently problem solve within minimum to no supervision, and have a high degree of independence in decision making
• Strong understanding of manufacturing methods & terminology

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.

The estimated base salary range for the Engineer 2 - Compliance role based in the United States of America is: $73,400 - $110,200. 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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative 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 offer opportunities to engage in social responsibility. 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. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. 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.