Network Engineer (Permanent/Full-Time)
About The Position
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. 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.
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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
