Principal Global LIMS & ELN System Specialist at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Apr, 26

Salary

188300.0

Posted On

09 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Lab Informatics, LIMS Implementations, ELN Implementations, Lab Operations, Supplier Management, Computerized System Validation, Regulatory Knowledge, Audit Experience, Cross-Functional Influence, Technical Fluency, Data Migration, Integrations, Cloud LIMS Architectures, On-Prem LIMS Architectures

Industry

Medical Equipment Manufacturing

Description

Recruiter: Spencer Gregory Hale Principal Global LIMS & ELN System Specialist About the role: The Principal Global LIMS & ELN System Specialist represents lab stakeholders and defines the strategy, roadmap, and validation plan for the Global LIMS & ELN. The person will leads cross‑functional delivery and vendor management to ensure the system is validated, adopted, and operationally successful. Your responsibilities will include: Global governance: define SOPs, master data standards, role‑based access, and harmonized workflows for all labs. Validation ownership: own IQ/OQ/PQ strategy, approve validation deliverables, and sign off go‑live and major upgrades. Vendor management: work with supplier quality to negotiate SLAs, manage escalations, and enforce vendor evidence requirements for releases and security attestations. Customization policy: set configuration vs customization rules and approve any custom development with business case and QA review. Change control: chair the global change control board, prioritize cross‑BU requests, and enforce testing and rollback criteria. Data migration & integrations: own migration acceptance criteria, instrument/API priorities, and traceability between ELN records and LIMS sample data. Training & adoption: define global training strategy, regional super‑user programs, and adoption KPIs. Risk & compliance: lead system risk assessments, accept residual risk, and escalate to executive sponsors when needed. Supports other preclinical systems as available. What we're looking for in you: Minimal requirements 10+ years in lab informatics, LIMS/ELN implementations, or lab operations. Deep experience with COTS LIMS/ELN deployments, supplier management, and computerized system validation (IQ/OQ/PQ). Strong regulatory knowledge (GxP, 21 CFR, ISO 13485) and audit experience. Proven ability to influence cross‑functional stakeholders without direct line authority. Technical fluency with integrations, data migration, and cloud or on‑prem LIMS architectures. Requisition ID: 620946 Minimum Salary: $ 99100 Maximum Salary: $ 188300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Principal Global LIMS & ELN System Specialist defines the strategy and roadmap for the Global LIMS & ELN, ensuring successful validation and operational performance. Responsibilities include global governance, validation ownership, vendor management, and training & adoption.