Senior CSV Engineer

Cambridge, MA, US • Posted 30+ days ago • Updated 7 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Data Quality
Testing
IQ
OQ
PQ
Acceptance Testing
Dashboard
Continuous Improvement
Release Management
Blueprint
SaaS
Documentation
Network
Quality Assurance
Project Governance
Account Management
Data Integrity
Computerized System Validation
Change Control
MAPPER
Management
Analytics
Veeva
Communication
Computer Science
Information Systems
Life Sciences
Bioinformatics
Data Engineering
SQL
Python
API
Extract
Transform
Load
Informatica
Talend
Meta-data Management
Regulatory Compliance
GxP
Auditing
Collaboration

Summary

Roles & Responsibilities: -

Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules.
Configure elluminate study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications.
Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams.
Develop dashboards/analytics across elluminate modules and monitor system performance, integrations, and governance logs.
Support project governance, process standardization, template reuse, and continuous improvement across functions while ensuring GxP and regulatory compliance.
Support account management, routine user access reviews and release management activities for 25+ Blueprint Medicines SaaS computerized systems that fall under GxP regulations.
Manage/Assist in creating Change Controls and System update-related documentation.
Interface effectively with system business owners, quality (QA), and associated partners.
Manage onsite/offsite GxP resources to ensure efficient communication and execution.
Schedule maintenance and manage incidents with outside vendor-network.
Collaborate with the QA organization to develop and execute scalable, risk-based, computerized systems validation (CSV) processes and procedures.
rrange regular project governance meetings for assigned projects.
ctively participate in project meetings and walkthroughs.
Manage and oversee Account Management & Security processes for all BPMC regulated Systems.
Interface effectively with system business owners, quality and associated vendors.
Stay current with US and international regulations, industry standards, and emerging topics pertaining to GxP Computerized Systems, Computer Systems Validation and Data Integrity.
Prepare, review, and approve GxP Computerized Systems Validation life cycle and Change Control documents.

Qualifications:

10+ years of relevant experience supporting GxP projects.
Hands-on familiarity with the elluminate platform and its modules (Mapper, Data Central, CTOA/Operational Analytics, Sample Management, Protocol Deviations, Clinical Analytics) or similar platforms.
Knowledge of Veeva preferred.
Strong verbal and written communication skills.
ble to work independently.
Bachelor's or Master's in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar.
Experience in clinical systems configuration, data engineering, clinical data platform delivery, or module implementations.
Proficiency in SQL, Python, API development/integration, ETL tools (Informatica/Talend/Fivetran), metadata management, and data lineage practices.
Strong knowledge of system validation frameworks and compliance (21 CFR Part 11, GxP, audit readiness).
Excellent ability to translate business requirements into technical configurations, collaborate with cross functional stakeholders, and deliver module-based solutions.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 596aa8e63615e504b5937e9b5289060e
Posted 30+ days ago

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Senior CSV Engineer

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Job Details

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