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Shrive Technologies

27 jobs near Columbus, OH

Shrive Technologies LLC

Oracle ERP SME

Plano, TX · On-site

Job Title: Oracle ERP SME Oracle ERP(GL, Fixed Asset,Financial Accounting hub,Project costing/Billing,Intercompany Billing) Oracle EPM (FCCS) Skills: FDI and Narrative reporting * Provide functional ...

Shrive Technologies LLC

API Integration Developer

Denver, CO · On-site

$51.75 - $68.75/hr

Role Overview: The Sr Software Engineer will design, develop, test, and support scalable software solutions, with a strong focus on APIs and customer integrations. Required Qualifications • Strong ...

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Lab Support IT administrator

Wilmington, OH • On-site

Shrive Technologies LLC
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Posted 7 days ago

Job description

Manufacturing Pharmacetical laboratory experienceRelevant Minimum Exp 8 to 10Laboratory 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:
    • User Requirements Specifications (URS)
    • Functional Requirements Specifications (FRS)
    • Design Specifications
    • Risk Assessments
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Validation Summary Reports
    • 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:
    • FDA 21 CFR Part 11
    • EU Annex 11
    • ALCOA+ Data Integrity Principles
    • GAMP 5 methodologies
    • 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:
    • Periodic System Reviews
    • Data Integrity Assessments
    • User Access Reviews
    • Audit Trail Reviews
    • Security Assessments
    • Technical Impact Assessments
    • 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:
    • 5 Why Analysis
    • Fishbone Analysis
    • Root Cause Analysis (RCA)
    • 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.
  • Manage local workstation permissions, privileged accounts, service accounts, and role-based access controls.
  • Conduct periodic access reviews to verify appropriate user permissions and segregation of duties.
  • Ensure identity and access management processes comply with GxP and data integrity requirements.
Cybersecurity & Endpoint Security:
  • Execute cybersecurity efforts supporting laboratory workstations and regulated systems.
  • Implement and support endpoint protection technologies including:
    • Antivirus solutions
    • Endpoint Detection and Response (EDR)
  • Assess cybersecurity risks associated with legacy operating systems and vendor-supported instrument software.
  • Develop and implement compensating controls for unsupported or restricted laboratory systems.
  • Support security monitoring, incident response, remediation activities, and vulnerability assessments.
  • Collaborate with Information Security teams to maintain secure laboratory environments while preserving validated system states.
Networking, Infrastructure & Firewall Technologies:
  • Provide engineering and support for laboratory networks and infrastructure.
  • Demonstrate advanced knowledge of:
    • TCP/IP Networking
    • DNS
    • DHCP
    • VLANs
    • Routing and Switching
    • Network Segmentation
    • Wireless Technologies
    • Firewall Technologies
  • Support the troubleshooting network connectivity supporting laboratory instruments, workstations, servers, and integrated business systems.
Third-Party Software & Technology Evaluation:
  • Assess third-party laboratory software, vendor applications, and supporting technologies for alignment with enterprise architecture, cybersecurity requirements, and regulatory expectations.
  • Evaluate technical specifications, software requirements, system architecture, and integration capabilities.
  • Identify security, compliance, operational, and supportability risks associated with proposed solutions.
  • Develop recommendations for software implementation, remediation, and lifecycle planning.
  • Partner with vendors and internal stakeholders to ensure compliance with corporate standards and industry best practices.
Technical Communication & Leadership:
  • Translate complex technical concepts into business-focused language for laboratory personnel, quality organizations, managers, and executive leadership.
  • Present technical risks, compliance findings, system health assessments, and strategic recommendations to non-technical stakeholders.
  • Develop executive summaries, technical reports, assessment findings, and decision-support documentation.
  • Serve as a trusted technical advisor for laboratory operations, validation, quality, and business leadership.
  • Facilitate cross-functional collaboration between IT, Cybersecurity, Quality Assurance, Validation, Engineering, Operations, and external vendors.
BASIC QUALIFICATIONS:Minimum Education:
  • Bachelor’s degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline.
  • Equivalent combination of education and experience may be considered.
Experience:
  • 5+ years of IT infrastructure, systems engineering, or systems administration experience.
  • 3+ years supporting regulated GxP systems within pharmaceutical, biotechnology, medical device, or life sciences organizations.
  • Experience supporting laboratory instrumentation and computerized systems validation.
  • Experience working within highly regulated environments subject to FDA and international regulatory requirements.
Technical Knowledge/Skills Needed:Required:
  • Microsoft Windows administration (Windows 7 through current supported versions).
  • Advanced Active Directory administration.
  • Expert-level Group Policy Object (GPO) administration and troubleshooting.
  • Local permissions and privileged access management.
  • Endpoint security technologies and cybersecurity controls.
  • Vulnerability management and system hardening.
  • Networking technologies including TCP/IP, DNS, DHCP, VLANs, routing, and switching.
  • Firewall technologies and network segmentation.
  • PowerShell scripting and automation.
  • Backup, disaster recovery, and business continuity processes.
  • Risk assessment and root cause analysis methodologies.
  • Audit trail review and user access review processes.
  • Computerized System Validation (CSV) methodologies.
  • Data Integrity principles and regulatory compliance frameworks.
Preferred:
  • VMware virtualization technologies.
  • Waters Empower, ThermoFisher Sample Manager, MODA-EM, or similar laboratory software platforms.
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