Senior Pharma CQV Engineer - Automation & IT

NNE; Clayton (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

PTO 160 hours

14 holidays

Health insurance

401(k) 8% company contribution

Parental leave 14 weeks

Life and disability insurance

Referral bonuses

Job summary

NNE in the United States is seeking an Automation & IT CQV Senior Engineer to lead commissioning, qualification and validation activities across pharma equipment, automation and facilities. You will plan, execute and document CQV deliverables, collaborating with Quality, Engineering and project teams to ensure compliant, production-ready systems.

You’ll work independently, mentor junior staff and may act as SME or lead CQV workstreams on diverse projects, from aseptic filling to packaging, with

Qualifications

• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences, or related field.
• 5+ years of commissioning, qualification, or validation experience in regulated manufacturing.
• Strong GMP knowledge and risk-based validation; familiarity with FDA expectations and EU Annex 15.
• Experience authoring, reviewing, and executing clear, traceable validation documentation.
• Experience with pharmaceutical manufacturing equipment and automation/manufacturing IT systems.

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 cross-functional coordination.
• 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.
• Coordinate CQV deliverables and communicate project status, risks, constraints, and escalations.

Job description

NNE in the United States is seeking an Automation & IT CQV Senior Engineer to lead commissioning, qualification and validation activities across pharma equipment, automation and facilities. You will plan, execute and document CQV deliverables, collaborating with Quality, Engineering and project teams to ensure compliant, production-ready systems.

You’ll work independently, mentor junior staff and may act as SME or lead CQV workstreams on diverse projects, from aseptic filling to packaging, with