IT Principal Systems Engineer

Overview

This position designs, analyzes, implements, and troubleshoots information systems and its components in a complex IT business information environment. Requires business area knowledge and computer expertise to provide in-depth support for IT related systems related to virtual environments, Storage area networks, hyperconvergence, Subject matter expert in Windows Administration, Active Directory PO experience, backups, datacenter management, application support related to new and existing laboratory and/or manufacturing applications.

Solves computerized system issues, analyzes information, implements new systems, and maintains and enhances existing solutions in accordance with corporate standards and guidelines. Collaborates with local and global IT teams to meet goals for both current and anticipated future needs for new and existing technologies, practices, and initiatives. Perform as an IT leader in working with business and IT peers to support business projects and troubleshoot IT related problems.

Provide Technical Mentoring to other IT staff.

• Design, implement, and maintain Windows Server environments, including physical and virtual server provisioning, monitoring, storage, and capacity planning
• Ensure server infrastructure meets security standards through patch management, vulnerability remediation, and hardening of Active Directory and OS
• Act as a high-level technical resource for complex server outages, performance issues, and root cause analysis.
• Create documentation for systems, configurations, and procedures, while recommending future infrastructure changes.
• Author, review, approve and execute computer systems validation deliverables.
• Perform and/or review periodic reviews of qualified computer systems maintained by the department.
• Provide computer system validation support for the IT department with a focus on the Quality Assurance requirements.
• Serve as a technical lead on multiple computer system validation projects, driving the technical implementation and design/configuration of these systems required to achieve group and corporate objectives (also reviewing validation documentation and executing IQ/OQ/PQ protocols as needed).
• Serve as a technical lead for the initiation and management of change controls related to computer systems.
• Ensure that validated computerized systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11).
• Identify compliance issues and process improvements related to the ongoing administration of computerized systems, implementing effective resolutions.
• Provide input to lead technical projects within the department, as needed.
• Work independently to draft/review system administration procedures and policies.
• Serve as a primary interface with system owners, IT, QA, and vendors related to computerized systems.

• Key contact for stakeholders/customers for IT related changes/incidents.

• Act as Lead/Subject Matter Expert among peers in the IT area.

• BS/BA in Computer Science or related field required (or equivalent work experience).
• 5+ years industrial experience, preferably in a GxP regulated environment
• Knowledge of 21 CFR Part 11.
• Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory environment and system applications.
• Experience with managing external (vendor, consultant) business partners.
• Minimum of 3+years of experience in the pharmaceutical or biotechnology industry.
• 5+ years of experience with supporting IT Foundational areas such as Virtual environments, Storage area networks, Active Directory POs, Backups, Datacenter Management, Business applications.
• 5+ years of advanced Windows Administration Support and Powershell
• Ability to work on multiple concurrent project initiatives.
• Application administration trouble shooting experience.

• Effective problem-solving and analytical skills to resolve operational problems.
• E…