Senior CQV Automation & IT Engineer

NNE Inc.; Powhatan (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

PTO + holidays

401(k) company contribution

Parental leave (14 weeks)

Job summary

NNE Inc. is seeking an Automation & IT CQV Senior Engineer to plan, execute, and deliver commissioning, qualification, and validation activities across pharmaceutical manufacturing systems.

You will lead CQV efforts for equipment, automation, laboratories, and facilities while coordinating with Quality, project teams, suppliers and customers. You will apply CQV expertise to DeltaV, Syncade, SCADA, PLC, and PAS-X, and contribute to the modernization of GMP utilities and related systems.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences, or a related discipline, or equivalent relevant experience.
• 5+ years of commissioning, qualification, or validation experience within pharmaceutical, biotechnology, medical-device, or other regulated manufacturing.
• Strong knowledge of GMP and risk-based validation, with familiarity with FDA expectations, EU Annex 15, GAMP 5, and applicable company procedures.
• Experience independently authoring, reviewing, and executing clear, traceable validation documentation.
• Experience with pharmaceutical manufacturing equipment, automation/manufacturing IT, laboratories, facilities, or utilities.
• Strong communication, practical problem-solving, and cross-functional collaboration skills.
• Ability to work independently, manage complex priorities, make decisions under uncertainty, and raise risks early.
• Preferred Qualifications
• Experience with DeltaV, Syncade, SCADA, PLC, PAS‑X, BMS, or similar pharmaceutical automation and manufacturing systems.
• Experience with electronic validation and quality systems such as TIMS (HP ALM) and Veeva QualityDocs/Vault Quality.
• Experience supporting FAT, system modernization, lifecycle replacement, or larger capital projects.
• Experience serving as a technical SME or leading defined CQV workstreams.

Responsibilities

• Plan, execute, and document Design Review/Qualification, IQ, OQ, PQ, and Process Validation activities based on project scope.
• Author and review validation plans, specifications, risk assessments, traceability matrices, protocols, reports, and other lifecycle documentation.
• Support commissioning and qualification readiness, including FAT activities and coordination across engineering, Automation & IT, Quality, suppliers, and operations.
• Investigate deviations and engineering changes, support Change Controls, and assess validation impacts.
• Create, revise, route, and maintain compliant electronic validation records in approved validation and quality systems.

Skills

CQV expertise

Hands-on delivery

Independent worker

Cross-functional collaboration

Strong communication

Problem solving

Project coordination

Education

Bachelor's or Master’s degree in Engineering/Automation/CS/Life Sciences

5+ years CQV/validation experience

GMP/risk-based validation knowledge

Tools

DeltaV

Syncade

SCADA

PLC

PAS-X

TIMS (HP ALM)

Veeva QualityDocs/Vault Quality

BMS

Job description

NNE Inc. is seeking an Automation & IT CQV Senior Engineer to plan, execute, and deliver commissioning, qualification, and validation activities across pharmaceutical manufacturing systems.

You will lead CQV efforts for equipment, automation, laboratories, and facilities while coordinating with Quality, project teams, suppliers and customers. You will apply CQV expertise to DeltaV, Syncade, SCADA, PLC, and PAS-X, and contribute to the modernization of GMP utilities and related systems.