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.Illumina is seeking a PLM Senior Analyst to support Product Lifecycle Management (PLM) operations across New Product Development and Commercial Operations. This role is responsible for managing change control processes, product configurations, document control, and master data governance while ensuring regulatory compliance, data integrity, and operational excellence.
The position also supports Illumina's digital transformation journey through the use of AI, automation, analytics, and digital tools to improve process efficiency and decision-making.
Key Responsibilities
- Create, manage, and drive Change Requests (CRs) and Change Orders (COs) through closure.
- Analyze change impact on products, documents, BOMs, specifications, and master data.
- Maintain accurate product and process configurations in PLM, SAP, and connected systems.
- Ensure compliance with GMP, GDP, FDA, and ISO requirements.
- Perform data quality reviews and risk assessments to ensure data integrity.
- Support AI-enabled, automation, and process improvement initiatives.
- Collaborate with R&D, Quality, Manufacturing, Regulatory, Supply Chain, and IT stakeholders.
- Drive continuous improvement through analytics and operational excellence practices.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field.
- 5-8 years of experience in PLM, Change Management, Master Data Management, Configuration Management, or Document Control within a regulated MedTech, Biotechnology, or Life Sciences environment.
- Experience with PLM platforms (Teamcenter, Windchill, Agile PLM, Enovia, Arena, etc.) and SAP.
- Strong analytical, problem-solving, and stakeholder management skills.
Preferred Qualifications
- Experience with Microsoft Copilot, Generative AI, Power BI, Power Automate, or similar digital tools.
- Knowledge of Data Governance and Master Data Management practices.
- Lean Six Sigma certification preferred.
- Experience supporting digital transformation and automation initiatives.
Regulatory Knowledge
- FDA 21 CFR Part 11, 820, and 809
- ISO 13485
- GMP, GDP, and Change Control processes
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.