Lab Support IT administrator

Position: Lab Support IT administrator

Location: Wilmington, OH***Onsite***

Duration: 1 Years

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

Maintain systems in a validated state through approved change control processes.

Support regulatory inspections, customer audits, quality audits, and compliance assessments.

Ensure compliance with:

o FDA 21 CFR Part 11

o EU Annex 11

o ALCOA+ Data Integrity Principles

o GAMP 5 methodologies

o Corporate cybersecurity and quality standards

Compliance Reporting, Assessments & Quality Systems

Perform and document periodic reviews and assessments of GxP systems to ensure ongoing compliance and operational effectiveness.

Generate and maintain:

o Periodic System Reviews

o Data Integrity Assessments

o User Access Reviews

o Audit Trail Reviews

o Security Assessments

o Technical Impact Assessments

o Compliance Status Reports

Analyze system trends, audit findings, and operational performance data to identify compliance risks and improvement opportunities.

Risk Assessment & Root Cause Analysis

Conduct technical and compliance risk assessments related to infrastructure, laboratory applications, instrument software, cybersecurity vulnerabilities, and system changes.

Evaluate risks affecting product quality, patient safety, data integrity, system availability, and regulatory compliance.

Lead investigations involving system failures, deviations, cybersecurity incidents, and compliance concerns.

Perform fault isolation, troubleshooting, and root cause analysis utilizing methodologies such as:

o 5 Why Analysis

o Fishbone Analysis

o Root Cause Analysis (RCA)

o Failure Mode and Effects Analysis (FMEA)

Develop corrective and preventive action plans (CAPAs) to address identified issues and prevent recurrence.

Document investigation findings, impact assessments, and remediation plans.

Identity & Access Management:

Administer Active Directory environments supporting laboratory and regulated systems.

Design, implement, and maintain Organizational Units (OUs), security groups, delegated administration models, and authentication services in partnership with the corporate Active Directory team.

Develop and maintain Group Policy Objects (GPOs) supporting security baselines, workstation hardening, application controls, and laboratory compliance requirements.