Network Engineer (Permanent/Full-Time)

Overview 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 #J-18808-Ljbffr CoreFactor