Lab System Support Specialist

TechDigital Group; West Point (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A technology solutions provider in Rahway, New Jersey, seeks an IT Support Specialist to build and support laboratory computing systems in a GMP environment. The role requires hands-on experience in various ITIL-based support tasks, excellent communication skills, and knowledge of GxP operations according to regulatory standards. Ideal candidates will ensure smooth IT operations while providing remote support and contributing to a knowledge management system. Competitive salary and benefits are offered.

Qualifications

• In-depth knowledge of GxP operations relevant to CFR 21 Part 11 requirements.
• Experience in supporting Lab/Manufacturing computer systems.
• Proficient in troubleshooting Tier 1–2 end-user issues.

Responsibilities

• Build and manage Lab/Manufacturing systems in GMP environments.
• Provide support and troubleshooting for Microsoft O365 applications.
• Monitor trends in systems support and address findings.

Skills

Hands‑on support experience

ITIL‑based knowledge management

GxP operations knowledge

Microsoft O365 proficiency

Strong communication skills

Tools

ServiceNow

Tanium

Acronis

Job description

Top 3 must have's

• Hands‑on support experience across diverse laboratory computing systems, including robotic, imaging, and chromatography acquisition and analysis systems, as well as high‑throughput label printers and barcode scanners.
• Disciplined ITIL‑based approach to ticket documentation and knowledge management, with consistent, accurate note capture and active contribution to a shared knowledge base.
• Experience as a change owner in a regulated (GxP preferred) environment, with the ability to align stakeholders and follow strict change‑management protocols.

JD

• In‑depth knowledge of GxP operations as it relates to the FDA’s CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP).
• Build, Install, Configure, Manage, and Administer Lab/Manufacturing computer systems in a regulated GMP environment.
  • Good understanding of Windows Desktop OS support tasks and ability to set up brand new systems.
  • Knowledge of simple AD account management and network connectivity requirements.
  • System imaging software experience and ability to learn new in‑house methods.
• Providing direct support to end‑users ranging from Tier 1–2 type issues.
  • Remote support for a third location (Boston).
  • Vendor support and account provisioning.
  • Work with vendor’s tech support teams to resolve application errors as needed; command of IT ticketing system use, with timely work note updates and effective workload management.
  • Dedicated support for the robotics PCD automation initiative – fault finding, coordination for new equipment setup, equipment moves.
  • Respond to IT support requests to address operational issues with enterprise and quality applications.
  • Meet with internal clients and stakeholders to diagnose software and middleware issues.
  • Proactively monitor and identify trends and behaviors in systems support and address the findings or elevate to other IT team resources.
  • Able to follow other specific troubleshooting steps and continuously update and create additional knowledge articles.
• In‑depth knowledge of Microsoft O365 applications and other productivity applications such as Adobe Acrobat.

Ideal candidates will have experience with

• Collaborating across business groups and sites to ensure global consistency.
• Continue to develop an understanding of the business processes and all applicable procedures.
• Contribute to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance.
• Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems.
• Serve as the System Owner/Manager and perform administrative tasks on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updates.
• Partner with local QA/QE to evaluate and test new upgrades/patches to Operating Systems/applications and write install instructions for Lab/MFG managed services support personnel.
• Participate in process re‑engineering workshops with business and IT stakeholders.
• Perform impact assessment on changing product capabilities, including impact to integrated (boundary) systems.
• Review/develop SOPs related to administration and installation of applications used in the lab/manufacturing environments.
• Enterprise system administration and monitoring tools such as Tanium, Eracent, Acronis, ServiceNow, BeyondTrust.