Engineer 2 - Compliance

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 Strategic Operations organization is looking for a high-potential engineer to support the Equipment Compliance and Reliability Engineering teams. The primary function of this role is performing investigations and corrective actions for equipment related quality records (NCRs, CAPAs, SCNs, etc.). In addition, the role will support high-impact reliability projects, such as maintenance dossiers, maintenance internalization, and spare parts onboarding. The role will work closely with Equipment Engineering, Manufacturing, Process Development, Quality and Supply Chain.

Responsibilities:

• Facilitate any complaints, CAPA and/or nonconformance meetings and prepare any investigation documentation associated with manufacturing compliance issues.

• Perform investigations and root cause analyses to identify solutions and corrective actions needed for issues identified in NCR, CAPA, Supplier Change Notifications (SCN), and other Quality Events.

• Monitor and analyze any potential trends in complaints, CAPA and/or nonconformances observed in Manufacturing.

• Track KPIs related to health of equipment life cycle metrics particularly those tied to compliance

• · Provide necessary training and support to ensure current Good Manufacturing Practices (cGMP) and regulatory requirement implementation and compliance within manufacturing.

• Identify and eliminate any compliance gaps in the manufacturing processes or documentation.

• Generate or maintain standard operating procedures/work instructions directly or indirectly linked to equipment reliability (PM procedures, Spare Parts Management, Planning and Scheduling, Maintenance Strategies etc.) 

• Participate in Kaizen events and help implement improvement initiatives such as 6S and other lean manufacturing programs.

• Promote continuous improvement activities and cost saving strategies to improve equipment availability, reliability, and operational stability 

• Lead continuous improvement initiatives from project definition and planning through execution

• Spearhead improvements to current business processes and identify processes that are not documented 

• Support troubleshooting of recurrent technical issues through leading and executing Root Cause Analysis work sessions 

• Provide support for CR/CNs across Strategic Engineering for initiatives and sustaining changes to owned documents

• Responsible for NPI projects maintenance transfer packages and content including Reliability Centered Maintenance (RCM), turnover packages, lock-out tag-out and maintainability reviews.

• 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:

• Strong background in cGMP Manufacturing (e.g. medical device, IVD, pharmaceutical industry).

• Knowledge of Quality System Regulations (QSR), 21 CFR Part 820 and ISO 13485.

• Knowledge of Change Management systems, ERP/MRP control systems (e.g. SAP).

• Knowledge of Electronic Manufacturing Execution Systems (e.g. Camstar) (Preferred).

• Knowledge of Nonconformance, CAPA, Compliant QMS (e.g. TrackWise, EtQ Reliance).

• Knowledge of Lean Tools and Root Cause Analysis methodologies.

• Experience in Internal Auditing (Preferred).

• Adaptable to rapidly changing priorities and be flexible to support operations in accordance with departmental and company schedules and priorities.

• Must be able to independently problem solve within minimum to no supervision and have a high degree of independence in decision making.

• Occasional travel, night and/or weekend work may be required to support 24-hour global manufacturing operation.

• Proven to work both independently and collaboratively with other team members delivering quality documentation with aggressive timelines.

• Excellent written and verbal communications skills.

• Strong presentation skills, including the ability to influence process change

• Excellent planning and organizational skills and detail oriented.

• Proficient in Microsoft Suite (Outlook, Word, Excel, PowerPoint, Visio etc.).

• While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear. Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds 

Education:

• Bachelor’s Degree in an engineering or scientific discipline

• Graduate Degree in an engineering or scientific discipline (Preferred)

• Minimum 3-5 years IVD industry experience in a regulated environment (FDA, EMA, ISO 13485)

• Minimum 2+ years of experience in a cGMP environment (e.g. medical device, IVD, or pharmaceutical industry)

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.