Lead IT Validation & Compliance (CSV) – GMP Site

BioSpace; West Lebanon (NH); On-site; USD 120,000 - 160,000; Full time

Job summary

Novo Nordisk in New Hampshire is seeking a Lead IT Validation & Compliance professional to provide SME guidance on CSV activities across a GMP bioproduction site in West Lebanon, NH. The role focuses on regulatory compliance, validation deliverables, and continuous process improvement.

The ideal candidate has extensive IT compliance and CSV experience, with English communication skills, and the ability to coordinate cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor's degree in Information Technology or related field; minimum seven (7) years IT compliance experience.
• Master’s degree in Information Technology or related field preferred with minimum five (5) years IT compliance experience.
• COBIT Certification preferred.
• Lean Six Sigma Green Belt or Black Belt preferred.
• Experience with electronic application lifecycle software (HP ALM) required.
• Experience as SME in audits and inspections.
• GxP, change management and deviation handling experience.
• Experience with Incident, Problem, and Change Management in IT.
• Excellent written and spoken English.

Responsibilities

• Computer Systems Validation Expert for IT infrastructure, systems, and computerized equipment supporting Laboratories, Manufacturing, and Business Areas.
• Ensure IT solutions comply with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
• Develop and review validation deliverables (URS, DQ, FMEA, Risk Assessments, FAT, SAT, IQ/OQ/PQ, SOPs).
• Conduct risk assessments and mitigation analyses for compliance issues.
• Provide guidance on validation and qualification requirements to project teams.
• Continuously monitor and improve CSV documentation and processes.
• Perform Quality Systems activities including Document Management, Change Control, Deviations, and CAPA’s.
• Write or revise procedures for CSV activities.
• Collaborate with Engineering to support validation, requalification, and maintenance programs.
• Lead CSV service delivery and handover to operations; maintain system documentation.
• Participate in audits and inspections; provide documentation to demonstrate validated state.
• Ensure all documentation meets regulatory requirements and Novo Nordisk standards.
• Mentor personnel; participate in process groups; deliver CSV training.

Skills

IT Compliance

CSV Validation

Regulatory Knowledge

Documentation

Risk Assessment

Audits & Inspections

Project Coordination

Leadership

Education

Bachelor's in IT

Master's in IT preferred

COBIT Certification

Lean Six Sigma Green/Black Belt

Tools

HP ALM

MS Office

Job description

Novo Nordisk in New Hampshire is seeking a Lead IT Validation & Compliance professional to provide SME guidance on CSV activities across a GMP bioproduction site in West Lebanon, NH. The role focuses on regulatory compliance, validation deliverables, and continuous process improvement.

The ideal candidate has extensive IT compliance and CSV experience, with English communication skills, and the ability to coordinate cross-functional teams in a fast-paced environment.