The Infrastructure Qualification Engineer will use a risk-based approach to ensure IT Infrastructure meets GxP Quality standards and regulatory requirements. This includes internally hosted and managed infrastructure as well as external, such as SaaS and PaaS. This will be done using GDP, SOPs, Work Instructions, forms, internal audits, 3rd party audits and staff training. This position will also drive the creation of Change Control, Deviation and CAPA records as needed to fulfill the goal of the IT Infrastructure unit.
Key Accountabilities/Core Job Responsibilities:
• Function as Qualification Lead on multiple assigned infrastructure projects for hardware replacements, upgrades, patches and/or modifications to IT infrastructure needed to support quality systems and other enterprise applications. Projects may include IaaS, PaaS, virtualization, and datacenter qualifications.
• Participate in the development and manage deliverables for the qualification aspects of the project, using risk-based approach to determine testing, documentation, and verification activities, with appropriate justification of the approach.
• As necessary, modify/create Qualification Plan, Protocols, and Test Plans, Risk / security Assessments, Reports, Trace Matrix and SOPs.
• Manage qualification testing coordinating documentation and testing activities. Generate test scripts, as needed. Execute testing as required
• Participate in and guide team in generating/modification design / configuration specifications, infrastructure landscape and network diagrams.
• Ensure qualification processes are executed as defined by Client policy and procedures.
• Support process of infrastructure change management and qualification procedures
• Development of Standard Operating Procedures (SOPs), work instructions, forms and other Infrastructure and commissioning deliverables to support the overall infrastructure project.
• Manage electronic routing of required documentation ensuring compliance to current procedures for electronic document management.
• Communicate status, solutions, and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project.
• Collaborate with vendor(s), quality, and technical individuals throughout project in generation of project / qualification required deliverables.
• Collaborate with Client Quality and Compliance unit staffs to ensure Infrastructure qualification projects are delivered on time and compliant to company and industry best practices.
Qualifications and Requirements:
• 7-10 years minimum experience in the Information Technology field.
• 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting IT Infrastructure Qualification projects.
• Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, GAMP and other regulations affecting IT Infrastructure security and compliance.
• Experience with SOP authoring relative to IT Infrastructure processes and applications.
• Excellent verbal and written communication skills.
• Ability to organize and present ideas in a convincing and compelling manner.
• Ability to troubleshoot issues and work independently with minimal direction.
• Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
• Bachelor's degree in business, computer science or related discipline.