Nick Lukkarila

About Nick Lukkarila

I enjoy analyzing and implementing cutting-edge technology to ensure data integrity and…

Experience

1. Senior Validation Engineer, Csa

   Andelyn Biosciences

   Apr 2025 — Present

   Develop and maintain validation lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications (FS/DS), Risk Assessments, Test Plans, Test Scripts, Traceability Matrices, Validation Summary Reports, and Periodic Review Reports. •Ensure adherence to CSA best practices, following risk-based testing strategies and streamlined documentation as well as FDA regulations (21 CFR Part 11, Part 210/211), GAMP 5, and applicable ICH guidelines. •Provide guidance to business system owners, project teams, and QA on compliant, risk-based validation strategies as the CSA subject matter expert. •Use Sware\'s Res_Q platform to manage the full validation lifecycle. •Own CSA-related SOPs, Work Instructions, and templates. •Perform Periodic Reviews, ensuring validated state is maintained and documented appropriately.•Author and execute test scripts following a risk-based testing strategy to focus on critical functionality. •Manage 3rd parties and other individuals as required to augment the testing team. •Collaborate and ensure proper qualification and documentation of underlying IT infrastructure components. •Provide compliance oversight of system changes, ensuring appropriate change control processes are followed within the ITSM framework. •Review and assess SaaS vendor validation packages for appropriateness, completeness, and alignment with internal requirements. •Ensure proper vendor assessments and documentation for cloud and SaaS solutions, ensuring alignment with GxP compliance expectations. •Collaborate with cross-functional teams (QA, IT, Business System Owners) to embed CSA processes into project lifecycles. •Participate in internal and external audits and inspections as a CSA subject matter expert. •Plan, coordinate, and manage site-specific validation project activities including protocol development/approval, work schedules, and lifecycle documentation.

Education

• Mountain State University

  Associate of Science - AS, Criminal Justice

  2008 — 2010

• Central Ohio Technical College

  Associate of Science (A.S.), Forensic Science and Technology

  2006 — 2008

• Mountain State University

  Bachelor of Science (B.S.), Forensic Investigations

  2008 — 2010

Skills

• Soldering
• Fingerprinting
• Electronics Repair
• Database Administration
• Computer Repair
• Icp-Ms
• Mobile Devices
• Android
• Xrf
• Microsoft Office
• Forensic Services
• Ftir
• Adobe Creative Suite
• Analytical Chemistry
• Icp-Oes
• Afis