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Network Engineer (Permanent/Full-Time)

CoreFactor Inc.

Albany, NY

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JOB DETAILS
SKILLS
Access Control, Administrative Skills, Audioconferencing, Authentication, Autoclave, Bar Code Labels and Equipment, Bar Code Printers, Biotech and Pharmaceutical, Business Intelligence, Business-to-Business (B2B), Change Control, Cleanroom, Code of Federal Regulations, Communication Skills, Computer Science, Computer Security, Computer Systems, Corrective and Preventative Action (CAPA) Systems, Data Lake, Data Recovery, Database Extract Transform and Load (ETL), Disaster Recovery, Document Scanners, Documentation, ERP (Enterprise Resource Planning), Email Security, Endpoint Security, Engineering, Enterprise Applications, Environmental Monitoring, FDA (Food and Drug Administration), Facilities Management, Firewalls, GxP, HIPAA (Health Insurance Portability and Accountability Act), Hardware Administration, Help Desk, ISO (International Organization for Standardization), Incident Response, Information Technology & Information Systems, Internet Security, Internet Service Providers, Laptop PC, Local Area Network (LAN), Machine Tool, Management of Information Systems/Technology (MIS), Manufacturing, Manufacturing Execution Systems (MES), Medical Equipment, Microsoft Access Database, Microsoft Product Family, Microsoft Windows Azure, Mobile Devices, NetSuite, NetSuite ERP, Network Architecture/Engineering, On Site Support, Onboarding, Oracle, Oracle Database, Pharmacy, Presentation/Verbal Skills, Printers, Problem Solving Skills, Process Validation, Project Management Professional (PMP), Quality Management, Remote Access, Reporting Dashboards, SAP, Security Assertion Markup Language (SAML), Security Monitoring, Security Patches, Single Sign-On (SSO), Standard Operating Procedures (SOP), Statement of Work (SOW), Surveillance, System Integration (SI), System Validation, Technical Support, U.S. National Institute of Standards and Technology (NIST), United States Drug Enforcement Agency (DEA), VLAN (Virtual Local Area Network), VPN (Virtual Private Network), Validation Plan, Vendor/Supplier Management, Videoconferencing, Wi-Fi, Wide Area Network (WAN), Work Breakdown Structure (WBS), Workstation Hardware, Writing Skills
LOCATION
Albany, NY
POSTED
1 day ago

CoreFactor is searching for a Network Engineer on a permanent/full-time basis for a client located in Albany, NY. 


This position requires the successful incumbent to be on-site five (5) days per week. 

 

THE OPPORTUNITY

We are looking for a hands-on IT & Network Engineer to build and operate the technology backbone of a brand-new 503B sterile manufacturing facility. This is not a steady-state help desk role - you will be standing up the network, the server room, the cleanroom IT hardware, and the regulated enterprise application stack from a clean slate, on an aggressive FDA-driven timeline. You will own every layer: structured cabling and cleanroom devices, switches and firewalls, 21 CFR Part 11-compliant enterprise systems, integrations with regulated equipment (particle counters, environmental monitoring, security access, label printers), and the day-to-day support that keeps the plant running. You will work alongside the Pharmacist-in-Charge, Quality Manager, and Facilities Manager to make sure every system is inspection-ready from day one.

 

WHAT YOU WILL DO

  • Build out and maintain the corporate and manufacturing network from the ground up: structured cabling, switching, Wi-Fi coverage for ISO-classified cleanrooms, firewalls, VPN, network segmentation between IT and OT (production equipment), and secure remote access for vendors and consultants
  • Specify, procure, install, and support all IT hardware - workstations, laptops, servers, printers, label and barcode printers, handheld scanners, conference room AV, badge readers, surveillance cameras, and ruggedized devices for gowned cleanroom use
  • Administer and support 21 CFR Part 11-compliant enterprise systems, including MasterControl QMS (eDMS, training, CAPA), NetSuite ERP, SuiteCommerce B2B storefront, DataNinja MES/inventory, and LEGISYM Express222 for DEA CSOS controlled-substance ordering
  • Configure and maintain integrations and data flows between regulated systems - QMS, ERP, MES, environmental monitoring (Dickson), particle counters, Doyle Security access control, and the Oracle NetSuite Analytics Warehouse (NSAW) data lake
  • Administer identity and access - Microsoft Entra ID (Azure AD), SAML/SSO across MasterControl, NetSuite, DataNinja, and LEGISYM, multi-factor authentication, conditional access, and role-based provisioning aligned to SOP-controlled job codes
  • Run the cybersecurity program at the engineer level: endpoint protection, email security, patch and vulnerability management, backup and disaster recovery, incident response runbooks, and controls aligned to NIST CSF and HIPAA where applicable
  • Execute Computer System Validation (CSV) and 21 CFR Part 11 tasks for GxP systems - validation plans, IQ/OQ/PQ protocols, audit trails, electronic signatures, periodic user access reviews, and inspection readiness
  • Provide hands-on, on-site IT support during FDA, DEA, and Board of Pharmacy inspections - producing audit trails, electronic records, and system documentation on demand
  • Manage IT vendors and SOWs day-to-day across the technology portfolio - MasterControl, NetSuite, DataNinja, LEGISYM, Oracle, Microsoft, ISPs, and managed service providers
  • Support the data and BI platform - ETL pipelines into the data lake, dashboards for operations and compliance reporting, and safe rollout of enterprise GenAI tooling (e.g., enterprise ChatGPT) with proper data governance
  • Follow PMO discipline for technology initiatives - project charters, WBS, change control, decision logs, and formal acceptance against PMI/PMP-aligned templates
  • Serve as Tier 1-3 support for all end users - onboarding/offboarding, account provisioning, hardware refresh, and cleanroom-floor issue resolution



Requirements

  • Bachelor's degree in Computer Science, Information Systems, Network Engineering, or a related technical discipline (or equivalent hands-on experience)
  • 5+ years of hands-on IT and network engineering experience, with at least 2 years in an FDA-regulated pharmaceutical, biotech, or medical device manufacturing environment
  • Proven track record building IT infrastructure from scratch - networks, servers, endpoints, cleanroom hardware, and security systems
  • Strong, current working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and Computer System Validation for GxP systems
  • Hands-on administration experience with at least two of: QMS platforms (MasterControl, Veeva, TrackWise), ERP (NetSuite, SAP, Oracle), and MES/inventory systems
  • Strong networking and cybersecurity skills - LAN/WAN/Wi-Fi design, firewalls, VLAN segmentation for OT/IT, VPN, SSO/SAML, MFA, EDR, and backup/DR
  • Experience integrating regulated equipment and instruments (environmental monitoring, particle counters, balances, autoclaves, security access) into enterprise systems
  • Comfortable being the on-site, hands-on technical owner in a small-but-growing company - racking switches one day and walking an FDA investigator through audit trails the next
  • Excellent written and verbal communication - able to brief inspectors, vendors, and executives with equal clarity


About the Company

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CoreFactor Inc.