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
Key Responsibilities
Technical Skills Required
Benefits & Perks
Job Description
Title: Network Engineer (GMP / Pharma Manufacturing Environment)
Location: Raleigh, NC - Hybrid
Will accept relocation candidates also.
Responsibilities:
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- 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
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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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