IT Validation & Compliance Leader | CSV Expert

Incendia Partners; West Lebanon (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

Incendia Partners in West Lebanon, NH is seeking an IT Validation & Compliance Lead to provide subject matter expertise in computer systems validation, IT compliance, and service delivery management across the site.

You will own the CSV lifecycle, ensure 21 CFR Part 11, EU Annex 11, and GAMP compliance, and collaborate with Engineering to hand over validated IT solutions to operations.

Qualifications

• Bachelor’s in IT or related field with 7+ years IT compliance experience.
• Master’s in IT preferred with 5+ years in pharma manufacturing.
• Experience validating IT systems in a GxP environment.
• Hands-on with HP ALM and ITIL-style change management.

Responsibilities

• Own the CSV lifecycle across IT infrastructure, systems, and equipment.
• Lead 21 CFR Part 11, Annex 11, and GAMP compliance.
• Author and review URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols.
• Manage Quality System activities: Document Management, CAPA, Change Control.
• Collaborate with Engineering on validation and requalification.
• Apply Lean/kaizen visual tools to improve the CSV program.

Skills

IT compliance

CSV expert

GxP experience

ITIL practices

Lean Six Sigma

COBIT

Education

Bachelor's in IT

Master's in IT

Tools

HP ALM

Job description

Incendia Partners in West Lebanon, NH is seeking an IT Validation & Compliance Lead to provide subject matter expertise in computer systems validation, IT compliance, and service delivery management across the site.

You will own the CSV lifecycle, ensure 21 CFR Part 11, EU Annex 11, and GAMP compliance, and collaborate with Engineering to hand over validated IT solutions to operations.