SME - Miscrosoft Windows,Microsoft Servers RDS,Touch Services

Job Summary

Senior Systems Analyst fulfills the tasks associated with those of a Senior IT Administrator/Engineer for a GxP laboratory environment and is responsible for the administration, engineering, security, compliance, validation, and lifecycle management of industrial Windows-based workstations and supporting infrastructure used to operate GxP-regulated laboratory instruments within a biopharmaceutical environment. This role provides technical leadership for laboratory computing systems supporting Quality Control (QC) and the Manufacturing Science and Technology (MSAT) labs The position serves as a key liaison between Information Technology, Quality Assurance, Validation, Engineering, Laboratory Operations, Cybersecurity, and third-party vendors to ensure laboratory systems remain secure, compliant, highly available, and inspection ready. The successful candidate combines strong systems engineering expertise, regulatory compliance knowledge, cybersecurity awareness, critical thinking, and the ability to communicate complex technical concepts to non-technical stakeholders. The ideal candidate work autonomously, is energized by exploring new technology, welcomes shifting priorities, and approaches every issue as a new challenge to tackle. The experienced candidate is someone that wants to make an impact within Quality Control and Manufacturing Science and Technology (MSAT) laboratories to support the advancement of new medicines through the execution of outstanding tactical and strategic information technology initiatives. Must have previous experience working with GxP Equipment including the and have worked on qualifying new systems per 21 CFR Part 11 requirements. Lab Equipment preferred.

Key Responsibilities

Laboratory Systems Administration • Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) and associated infrastructure supporting analytical and manufacturing laboratory instruments. • Install, configure, upgrade, patch, and maintain operating systems, instrument software, middleware, and supporting applications. • Manage complete lifecycle activities including provisioning, imaging, deployment, upgrades, migrations, validation support, and decommissioning. • Perform advanced hardware and software troubleshooting for instrument-attached workstations while minimizing laboratory downtime. • Coordinate upgrades, migrations, software releases, and system enhancements with laboratory personnel, validation teams, and equipment vendors. • Support business continuity, disaster recovery, and backup/recovery activities for laboratory systems. GxP Compliance, Validation & Data Integrity • Ensure laboratory systems operate in compliance with GMP, GLP, GCP, FDA, and other applicable regulatory requirements. • Support and maintain validated systems through established Computer System Validation (CSV) methodologies. • Author, review, and execute validation documentation as required which may include: o User Requirements Specifications (URS) o Functional Requirements Specifications (FRS) o Design Specifications o Risk Assessments o Installation Qualification (IQ) o Operational Qualification (OQ) o Performance Qualification (PQ) o Validation Summary Reports o Traceability Matrices Compliance Reporting, Assessments & Quality Systems Risk Assessment & Root Cause Analysis

Skill Requirements

Good Hands on experience in Laboratory support Senior Systems Analyst to support Wilmington IT Operations PRIMARILY Windows Systems

Other Requirements

  Good Hands on experience in Laboratory support Senior Systems Analyst to support Wilmington IT Operations PRIMARILY Windows Systems