Senior CSV Engineer

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 to 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.
• Arrange regular project governance meetings for assigned projects.
• Actively participate in project meetings and walkthroughs.
• Manage and oversee Account Management & Security processes for all BPMC regulated Systems.
• 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.

• 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.
• Able 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.

Mid‑Senior level

Contract

Pharmaceutical Manufacturing