JC Automation Corp is hiring a Data Engineer / Data Analytics Specialist to support global pharmaceutical manufacturing clients by implementing and replacing Rockwell PharmaSuite MES. The role focuses on validated SQL and Power BI analytics within a GxP-regulated environment for manufacturing, quality, and operations reporting.
Responsibilities
- Design and develop analytical SQL views and data models on PharmaSuite MES data, following established corporate SQL and programming standards.
- Build and maintain Power BI semantic models, including DAX measures and dashboards for manufacturing and quality reporting (such as yield, defects, IPC, and order status).
- Collect, analyze, and document site requirements, and manage them through the change and validation lifecycle using ALM and ServiceNow Change Requests.
- Create GxP and GMP-compliant documentation, including requirements, risk and impact analyses, implementation guides, test evidence, and source code review artifacts.
- Support deployments and site replication across environments (DEV, TEST, PROD) with environment verification.
- Troubleshoot data discrepancies, resolve RITMs and incidents, and perform root cause analysis.
- Optimize query performance while ensuring data quality, integrity, and security.
- Collaborate with geographically distributed teams across time zones and cultures in English.
Required Qualifications
- Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field, or equivalent work experience.
- Experience working in a regulated pharmaceutical or life sciences environment, including GxP, GAMP 5, and 21 CFR Part 11.
- Strong SQL skills (T-SQL / SQL Server) and relational data modeling ability.
- Hands-on Power BI experience, including Power Query, DAX, and data modeling.
- 3+ years of experience in data analytics or reporting, ideally within pharmaceutical, biotech, or medical device manufacturing.
- Knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles (ALCOA+).
- Fluency in English, written and spoken.
Technologies
Rockwell PharmaSuite MES, SQL, T-SQL, SQL Server, Power BI, Power Query, DAX, ALM, ServiceNow Change Requests, GxP, GMP, GAMP 5, 21 CFR Part 11, ALCOA+, DEV, TEST, PROD, RITMs, Azure SQL, Azure Web Apps, Azure AD authentication, Always On Availability Groups, Denodo, Python, HTML, CSS, JS, GitHub, Power Automate, CSV, Agile, EBR, batch records, MES, Data Governance, Master Data Management, Business Intelligence, MES platforms, Rockwell PharmaSuite.
Preferred Qualifications
- Experience with MES platforms, ideally Rockwell PharmaSuite, or with batch records, EBR, and manufacturing execution data.
- Experience with computer system validation (CSV) and documentation under a formal validation plan.
- Python for data analysis and automation; familiarity with HTML/CSS/JS for lightweight web tools.
- Cloud experience, preferably Azure, including Azure SQL, Azure Web Apps, and Azure AD authentication.
- Familiarity with SQL Server high availability (Always On Availability Groups) and with Denodo or other data virtualization layers.
- Experience with Agile practices, GitHub, and workflow automation using Power Automate.
- Ability to review and recommend design patterns, performance optimization, and deployment strategies.
- Knowledge of Data Governance, Master Data Management, and Business Intelligence concepts.
- Spanish, Portuguese, Japanese, or other language skills are a plus; English is required.
Soft Skills
- Attention to detail and a strong quality mindset in a regulated environment.
- Clear written and verbal communication with technical and non-technical stakeholders.
- Ownership to manage multiple deliverables, dependencies, and deadlines.
- Curiosity and willingness to challenge assumptions using data.
- Self-directed and organized approach to managing several site deliverables at once.
- Comfort collaborating with remote teams across time zones.
Location and Experience
- Location: Carolina, PR (onsite)
- Minimum Experience: 3 years