Take over the responsibility as a System Owner/Local Product Owner for Manufacturing IT Applications in a 24×7 Good Manufacturing Practice (GMP) environment.
Responsible for the overall procurement, development, integration, modification, operation, maintenance, validation, and retirement of site specific OT systems. (LyoPlus, Ellab, WAGIT- Wireless Glove Integrity Testers, FIT – Filter Integrity Testers, and SRS – Site Reporting System)
Troubleshoot immediate system issues, and inquiries as they arrive during normal business hours
Participate in an after hours on-call support rotation
Determine and mitigate any risks associated with integration and/or upgrade of administered systems
Host/guide/monitor vendors on site for activities related to administrated systems
Perform system periodic reviews. This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.
Responsibility for the Periodic System Audit Trail Review
User account auditing, provisioning, resets and activation for all IT and OT systems
Work with business process owners to upgrade/patch and make changes to the system to ensure GMP compliance.
Review ServiceNow tickets and either address them or route them to the SME
Creating and maintaining system lifecycle documents and procedures using document management systems (Veeva, Condor, eVal Roche)
Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).
Develop, maintain, and practice Disaster Recovery and backup/restore
Through Agile delivery model, provide leadership, technical expertise, and local implementation experience as a member of Build and Run Squads.
Requirements & Skills:
Bachelor’s degree in Engineering (Computer/Automation Engineering preferred)
Minimum 5 years of experience in system and/or network administration
Prior experience in working closely with IT OT providers/vendors
Biopharmaceutical or similar Manufacturing domain knowledge
Experienced with troubleshooting OT systems hardware and software
System administration and/or system design, supporting multiple platforms and applications in a cGMP environment
Windows Server and Network Administration proficiency
Experience with industrial data and control interfaces, preferably OPC and OPC-UA
SQL Database Server proficiency. Knowledge of SQL Database Cluster (Always ON), is a plus
Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment
Computer System Validation (CSV) and Computer System Assurance (CSA)
Keep abreast of key Manufacturing IT trends and be curious – Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
Entrepreneurial mindset e.g. “automating automation”
