Sr. Staff, Product Lifecycle Management Operations

Illumina
296d$126,800 - $190,200

About The Position

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.

Requirements

  • ISO 13485 and GMP knowledge, 21 CFR Part 820, 21 CFR Part 11
  • Detail oriented, proactive, works independently, works well with others
  • Flexible, able to adapt quickly to change, work overtime as needed
  • Technical background in a manufacturing environment - preferably in life science or medical device
  • Good communication skills both oral and written
  • ECR/ECO processing experience
  • Experience working with teams across multiple functions
  • PLM experience with Teamcenter and SAP preferred
  • Good working knowledge of ERP/MRP systems (SAP preferred)
  • High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
  • Proficient in use of Microsoft Office (Word, Excel, Outlook, Powerpoint)

Responsibilities

  • Responsible for owning End-to-End Business Process Maps and Data Process Maps for PLM Ecosystem
  • Responsible to map out cross-functional users and roles to support PLM Operations
  • Responsible for the accuracy of system data through process evaluation and conducting appropriate reviews to ensure Data Integrity across PLM ecosystems
  • Conduct value stream and critical path analysis using PLM Data Process Maps to ensure alignment with PLM KPIs/Metrics
  • Identify and implement corrective measures for data or process gaps based on audit findings and process evaluations
  • Ensure thorough, complete, and timely communication with all necessary stakeholders to verify completion of commitments, notify all parties of any potential slippage issues, and provide updates on timelines and responsibilities
  • Enable and provide necessary support for Change Request (CR) and Change Orders for Enterprise Document Control, Item Master Data Management and BoMs
  • Enable and provide necessary support for Create and redline BOMs and other product documentation such as specifications
  • Understand complex BOM structures and how BOMs should be structured for maximum effectiveness in PLM and ERP
  • Understand implications of PLM/ERP changes to downstream cross functional areas and systems
  • Perform complex where used BOM Analysis to identify impact of change - specifically Changes impacting DMR, and DHF
  • Review incoming change requests and prioritize appropriately and group changes together for efficient processing
  • Work with Subject Matter Experts (SMEs) to ensure that change orders have all required information, such as justification for change, supporting documentation, and disposition plan
  • Incorporate redlines into final versions of documents
  • Facilitate the resolution of ECR/ECO issues
  • Track changes throughout the change control process to ensure accurate and speedy processing
  • Review implementation activities to ensure the change has been completed properly and perform effectiveness check
  • Support process improvement projects directly impacting the PLM Operations

Benefits

  • Access to genomics sequencing
  • Family planning
  • Health/dental/vision
  • Retirement benefits
  • Paid time off
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