Mason Bjerke Email & Phone Number

Fargo, North Dakota, United States

• Managing two groups. Accountable for maintaining the company’s Global Data Integrity (DI), Computerized System Validation (CSV), and IT Help Desk Programs for all of Aldevron’s sites.
• Implemented system monitoring solutions for instant notification of critical systems/services. Providing visual status updates of data closets.
• Lead Aldevron process improvements around OT network build-outs, new site build-outs, fill-finish suites, identity management, and asset sustainability.
• Lead Danaher projects around digital estate management, technology business management (TBM), and OneSupport (MSP, help desk centralization).
• Implemented SLAs and KPIs around the help desk with visual management boards.
• Supported system integrations and validation of central data historians, LIMS, and MES.

Fargo, North Dakota, United States

• Established the computer system validation (CSV) program and SOPs. Managing the CSV group.
• Speak to clients and regulatory auditors (EU & FDA) as subject matter expert for IT GxP compliance, computer system validation, 21 CFR Part 11 compliance, and data integrity.
• Participated in Kaizen events to support QC / GMP manufacturing groups. Revising Audit Trail review procedures to remove 12 days of lead time.
• Implemented an electronic validation management system to remove paper-based execution and review. Cutting GMP system release times by 16 days.

Fargo, North Dakota, United States

• Complete retroactive data integrity project plan for GMP manufacturing and QC systems. Following standard operating procedures to remediate gaps and provide a final summary report.
• Created standard operating procedures and data integrity controls that cover IT GxP compliance (21 CFR Part 11) for access control, electronic records/signatures, backup and archiving, date and time management, system.
• Implemented new GMP manufacturing and quality testing systems at both sites so that they meet data integrity and 21 CFR Part 11 requirements following GAMP 5.

Fargo, North Dakota Area

• Domain administrator. Configured, supported, and maintained infrastructure information systems.
• Restructured AD domain, implemented privilege accounts, and supported Microsoft tenant migration.
• Implemented ITSM and CMDB for the IT. Integrated IT tools (ZenDesk, Meraki, AsseSonar, Nagios, Open-AudIT) into one “ecosystem” for automated inventory and tracking.
• Implemented infrastructure disaster recovery solutions (virtual replication and backup).
• Implemented a knowledge base for internal IT and external clients.

Fargo, North Dakota

• Technical administrator for all RTS call centers across 4 countries.
• Provide a single point of contact for any site-related IT issue including severity 1 and 2 incidents.
• Managing the call centers servers, workstations, software, networks, telephony system, data centers, and more. Part of the Server Operations team for RTS (Server SME).

Fargo, North Dakota Area

• Troubleshooting connectivity and technology related issues for the client across North America. Troubleshooting these issues involve: running scripts, using Samba, RDP, Hardware issues for multiple devices, and.
• Provided support to other agents that need assistance, guidance, or escalations with technical issues.

Associate’S Degree, Computer And Networking Technologies

Activities and Societies: Advisor on the Northland Board of Advisory CommiteeCourses include Visual Basic Programming, Information.

Certification, Computer Systems Networking And Telecommunications

Complete Networking I, Networking II, Networking III, and Networking IV. They consists of routing and switching essentials, connecting.