Sr PLM Analyst

Job highlights

• 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.
• Create,manage,and drive Change Requests (CRs) and Change Orders (COs) through closure. . Analyze change impact on products,documents,BOMs,specifications,and master data.

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 Illuminas 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

• Bachelors 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

This role is not eligible for visa sponsorship.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.