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Description
Job Purpose:
We are seeking an analytically driven and detail-oriented Database Implementation & Migration Specialist to lead the technical transition of our computerized maintenance management system (CMMS) from our legacy system. This targeted role is specifically designed to spearhead our migration from Indy Soft to a fully validated Blue Mountain RAM cloud environment. The ideal candidate possesses deep expertise in structural data relational modeling, data cleaning, and workflow alignment. You will bridge the gap between our historical metrology data and the rigorous, FDA 21 CFR Part 11/GMP compliant requirements of the Blue Mountain ecosystem.
Essential Duties And Responsibilities
- System Migration & ETL Execution: Map, extract, transform, and load (ETL) complex historical data including gauge records, asset history, calibration certificates, and tool tracking logs from the legacy Indy Soft database into Blue Mountain RAM
- Relational Database Alignment: Analyze the current database schemas and restructure asset tracking hierarchies to match Blue Mountain's cloud-native, multi-level parent/child asset structures
- Workflow & Event Mapping: Translate Indy Soft’s event driven workflows, check-in/out protocols, and scheduling metrics into Blue Mountain’s automated pre-validated maintenance and calibration routing paths
- Validation & Data Integrity (GMP): Ensure absolute data preservation during migration. Collaborate with Quality Assurance to support data verification protocols, IQ/OQ/PQ processes, electronic signatures, and audit trails required for FDA compliance
- Analytics & Reconciliation Reporting: Utilize advanced Excel, Visual Basic (VBA), or PowerBI to build data-reconciliation models and track migration metrics, identifying and correcting anomalies in process tolerances or calibration intervals
- SOP Development/Technical Training: Document new standard operating procedures (SOPs) for the Blue Mountain database environment. Design and execute system training modules to transition calibration and maintenance technicians, metrology leaders and equipment owners from Indy Soft interfaces to Blue Mountain
- Program work plan templates, measurement data templates, work orders, and schedules into the BMRAM application.
Supplemental Functions
- Experience: 5+ years of database development, data engineering, or systems administration experience with a heavy emphasis on data migration within a regulated environment (Life Sciences, Pharma, Biotech, or advanced manufacturing)
- Software Platforms: Direct hands-on configuration or administrative familiarity with Indy Soft Calibration Management and/or Blue Mountain RAM is heavily preferred. Experience writing clean data extraction routines is required
- Data Tools: Expert proficiency with relational database design logic, Excel data modeling, Visual Basic (VBA), and PowerBI reporting
- Compliance Mindset: Strong understanding of Quality Management Systems (QMS), Root Cause Analysis, Process Validation (IQ/OQ/PQ), and data integrity standards under FDA regulations
- Attributes: Exceptional precision, strong forward-thinking technical problem-solving capabilities, and the capacity to operate as a self-guided learner during major system architecture
Job Specifications And Qualifications
- Experience: 5+ years of database development, data engineering, or systems administration experience with a heavy emphasis on data migration within a regulated environment (Life Sciences, Pharma, Biotech, or advanced manufacturing).
- Software Platforms: Direct hands-on configuration or administrative familiarity with Indy Soft Calibration Management and/or Blue Mountain RAM is heavily preferred. Experience writing clean data extraction routines is required.
Knowledge & Skills
- Data Tools: Expert proficiency with relational database design logic, Excel data modeling, Visual Basic (VBA), and PowerBI reporting
- Compliance Mindset: Strong understanding of Quality Management Systems (QMS), Root Cause Analysis, Process Validation (IQ/OQ/PQ), and data integrity standards under FDA regulations
- Attributes: Exceptional precision, strong forward-thinking technical problem-solving capabilities, and the capacity to operate as a self-guided learner during major system architecture updates
Education/Experience
- Bachelor’s Degree in Systems Engineering, Computer Science, Chemical/Process Engineering, or a highly technical discipline
- Certifications: Six Sigma Green Belt (assisting with lean data mapping), Project Management Professional (PMP), or specific vendor-certified database credentials
Working Conditions / Physical Requirements: Work is primarily performed in a climate-controlled office or remote setting sitting at a desk. However, regular presence can be required on the active manufacturing, cleanroom, or laboratory floors to audit physical assets and verify database tracking accuracy
- Collaboration: Regular collaboration in active team settings, technical sprint meetings, and training spaces. When on the manufacturing floor, the environment may include standard industrial noise, requiring adherence to site safety protocols
- Project Constraints: Driven by rigid software go-live timelines and system deployment windows. Occasional off-hours, evening, or weekend work may be required during the final cut-over and data-load phases to minimize operational downtime
