Senior CQV Engineer – Automation & IT (Pharma)

NNE Inc.; Clayton, Northern (NC, KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

PTO 160 hours

Paid holidays

Health, dental, and vision insurance

401(k) with company contribution

Parental leave (14 weeks)

Life and disability insurance

Employee referral bonuses

Job summary

NNE Inc. in the United States seeks an Automation & IT CQV Senior Engineer to lead commissioning, qualification, and validation activities across pharmaceutical manufacturing systems and projects.

You will work independently while coordinating with engineering, Quality, project management, suppliers, customers, and other stakeholders. Depending on project scope, you may serve as a technical SME or lead CQV workstreams.

Qualifications

• Bachelor’s or Master’s degree in Engineering or related discipline.
• 5+ years of commissioning, qualification, or validation experience in regulated manufacturing.
• Strong GMP knowledge and risk-based validation.
• Experience authoring, reviewing, and executing validation documentation.
• Experience with pharmaceutical equipment, automation, or labs.
• Excellent communication and cross-functional collaboration.
• Ability to work independently and manage complex priorities.

Responsibilities

• Plan, execute, and document IQ/OQ/PQ and Process Validation activities.
• Author and review validation plans, risk assessments, traceability matrices, protocols, reports.
• Support FAT activities and cross-functional coordination.
• Investigate deviations and support change controls.
• Maintain electronic validation records in validated systems.
• Coordinate CQV deliverables and communicate project status.
• Lead defined CQV workstreams or act as SME.

Skills

CQV expertise

Independent delivery

Cross-functional collaboration

Communication

Problem solving

Project leadership

Education

Bachelor’s or Master’s degree in Engineering/Automation/CS

5+ years CQV/validation experience

Tools

DeltaV

Syncade

SCADA

PLC

PAS-X

BMS

TIMS (HP ALM)

Veeva QualityDocs/Vault Quality

Job description

NNE Inc. in the United States seeks an Automation & IT CQV Senior Engineer to lead commissioning, qualification, and validation activities across pharmaceutical manufacturing systems and projects.

You will work independently while coordinating with engineering, Quality, project management, suppliers, customers, and other stakeholders. Depending on project scope, you may serve as a technical SME or lead CQV workstreams.