Sr. Staff, Product Lifecycle Management Operations

Posted 6 Days Ago
Be an Early Applicant
10 Locations
127K-190K Annually
Senior level
Healthtech • Biotech
The Role
The role entails managing the Product Lifecycle Management (PLM) operations, ensuring data integrity, conducting process evaluations, and facilitating changes in engineering documentation. Responsibilities also include mapping business processes, collaborating across functions, and driving process improvement initiatives.
Summary Generated by Built In

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:

  • 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

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:

  • 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)

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

The estimated base salary range for the Sr. Staff, Product Lifecycle Management Operations role based in the United States of America is: $126,800 - $190,200. 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.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. If you require accommodation to complete the application or interview process, please contact [email protected]. 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.

Top Skills

21 Cfr Part 11
21 Cfr Part 820
Erp
Gmp
Iso 13485
MS Office
Mrp
Plm
SAP
Teamcenter
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The Company
HQ: San Diego, CA
7,400 Employees
On-site Workplace
Year Founded: 1998

What We Do

Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.

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