Network Engineer - GMP/Pharma Manufacturing Environment

kaav inc • United State
Relocation
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AI Summary

Design and manage LAN/WAN, wireless, and SD-WAN infrastructure across lab, manufacturing, and corporate spaces. Ensure GMP-area network changes comply with 21 CFR Part 11, GAMP 5, and internal change control SOPs. Support IQ/OQ/PQ validation protocols and prepare audit documentation for FDA inspections and SOC 2 audits.

Key Highlights
GMP/Pharma manufacturing environment with regulated system validation requirements
Network design and management across lab, manufacturing, and corporate spaces
Compliance with 21 CFR Part 11, GAMP 5, and change control SOPs
Key Responsibilities
Design and manage LAN/WAN, wireless, and SD-WAN infrastructure across lab, manufacturing, and corporate spaces
Maintain IT/OT network segmentation between corporate/lab and manufacturing floor (process control, EMS, HVAC, cleanroom systems)
Support IQ/OQ/PQ validation protocols — provide network diagrams, configuration baselines, and change records for regulated systems
Ensure GMP-area network changes comply with 21 CFR Part 11, GAMP 5, and internal change control SOPs
Manage firewalls, NAC, IDS/IPS, and network access logging aligned with NIST SP 800-171 and NIST CSFP
Prepare network documentation for FDA inspections, SOC 2 audits, and pre-IPO due diligence
Design HA/failover architecture to meet commercial manufacturing uptime requirements
Contribute to SOX ITGC documentation in preparation for public offering
Maintain audit-ready documentation: topology diagrams, IPAM, configuration repositories, and runbooks
Technical Skills Required
Cisco Juniper Aruba BGP OSPF VLANs QoS SD-WAN IT/OT network design IQ/OQ/PQ validation FDA validation lifecycle CSV/CSAC AWS hybrid connectivity VPN Private endpoints Firewalls NAC IDS/IPS Network access logging NIST SP 800-171 NIST CSFP HA/failover architecture SOX ITGC documentation
Benefits & Perks
Hybrid work arrangement
Relocation assistance available

Job Description


Title: Network Engineer (GMP / Pharma Manufacturing Environment)

Location: Raleigh, NC - Hybrid


Will accept relocation candidates also.


Responsibilities:

  • Design and manage LAN/WAN, wireless, and SD-WAN infrastructure across lab, manufacturing, and corporate spaces
  • Maintain IT/OT network segmentation between corporate/lab and manufacturing floor (process control, EMS, HVAC, cleanroom systems)
  • Support IQ/OQ/PQ validation protocols — provide network diagrams, configuration baselines, and change records for regulated systems
  • Ensure GMP-area network changes comply with 21 CFR Part 11, GAMP 5, and internal change control SOPs
  • Manage firewalls, NAC, IDS/IPS, and network access logging aligned with NIST SP 800-171 and NIST CSF
  • Prepare network documentation for FDA inspections, SOC 2 audits, and pre-IPO due diligence
  • Design HA/failover architecture to meet commercial manufacturing uptime requirements
  • Contribute to SOX ITGC documentation in preparation for public offering
  • Maintain audit-ready documentation: topology diagrams, IPAM, configuration repositories, and runbooks


Required Qualifications:

  • 5+ years of network engineering, with at least 2 years in a GMP or regulated environment (pharma, biotech)
  • Hands-on expertise with Cisco, Juniper, or Aruba platforms; strong command of BGP/OSPF, VLANs, QoS, and segmentation
  • Experience with IT/OT network design in manufacturing environments
  • Familiarity with FDA validation lifecycle (IQ/OQ/PQ) and the role of network infrastructure in CSV/CSA
  • Cloud networking experience: AWS hybrid connectivity, VPN, private endpoints

Note: Highlighted in Yellow is MUST.


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